Over-the-counter drug · OTC MONOGRAPH DRUG

Mineral Lip Sunscreen (Titanium dioxide, zinc oxide) NDC 85581-212

Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g · Stick · Topical · Helen's Haven

NDC codes

FDA NDC Directory
Product NDC (as listed)85581-212Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85581-0212Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
85581-212-4585581021245855810212451 CYLINDER in 1 CARTON (85581-212-45) / 4.5 g in 1 CYLINDERMarketed from Dec 1, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Mineral Lip Sunscreen
Generic name (nonproprietary)
titanium dioxide, zinc oxide
Active ingredients
Zinc oxide — 55 mg/gTitanium dioxide — 40 mg/g
Dosage form
Stick
Route
Topical
Labeler
Helen's HavenNDC labeler code 85581
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 020
Marketing start
Listing expires
Identifiers
Product ID 85581-212_461667e5-bc82-b4f0-e063-6294a90a2ae4SPL ID 461667e5-bc82-b4f0-e063-6294a90a2ae4SPL set ID 36c4a27b-96e9-4f30-e063-6294a90a5655UNII SOI2LOH54Z, 15FIX9V2JPUPC 0385581212456

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N485581021245 followed by a unit qualifier and the quantity

Package 85581-0212-45. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Full label on DailyMed (opens in a new tab)

About NDC 85581-212

What is NDC 85581-212?
85581-212 is the product NDC for Mineral Lip Sunscreen, Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g stick, listed with the FDA by Helen's Haven. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mineral Lip Sunscreen (Titanium Dioxide, Zinc Oxide).
What is the active ingredient?
Zinc oxide, Titanium dioxide.
Who is the labeler?
Helen's Haven, NDC labeler code 85581. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mineral Lip Sunscreen?
14 other product NDCs are listed under this name. See all Mineral Lip Sunscreen NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Mineral Lip Sunscreen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mineral Lip Sunscreentitanium dioxide, zinc oxideTitanium dioxide 40 mg/g; Zinc oxide 55 mg/gStickTopicalUNDRBUDR, LLC87572-21287572-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideTitanium dioxide 40 mg/g; Zinc oxide 55 mg/gStickTopicalHealthy Skin & Body LLC85726-21285726-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideZinc oxide 55 mg/g; Titanium dioxide 40 mg/gStickTopicalLUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER85625-21285625-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideTitanium dioxide 40 mg/g; Zinc oxide 55 mg/gStickTopicalASHLEY SAMAI85862-21285862-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideTitanium dioxide 40 mg/g; Zinc oxide 38 mg/gStickTopicalCAPE COD SKIN CARE CO. INC.85627-21285627-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideZinc oxide 55 mg/g; Titanium dioxide 40 mg/gStickTopicalMILESTHETICS LLC85888-21285888-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideTitanium dioxide 40 mg/g; Zinc oxide 55 mg/gStickTopicalADVANCED AESTHETICS SKIN CARE STUDIO, INC85325-21285325-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideZinc oxide 55 mg/g; Titanium dioxide 40 mg/gStickTopicalThe Essential Brazilian Spa LLC85492-21285492-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideTitanium dioxide 40 mg/g; Zinc oxide 55 mg/gStickTopicalMantra Wellness Spa85377-21285377-0212-45
Mineral Lip Sunscreentitanium dioxide, zinc oxideZinc oxide 55 mg/g; Titanium dioxide 40 mg/gStickTopicalHALEM DERMATOLOGY PLLC85413-21285413-0212-45

All 15 Mineral Lip Sunscreen NDCs

Other NDCs under M 020

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 020
ProductStrengthForm · routeLabelerProduct NDC
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreenavobenzone, octisalate, octocryleneAvobenzone 30 mg/mL + 2 more ingredientsLotionTopicalWALGREEN COMPANY0363-0172
Walgreens 100 Sheer Broad Spectrum SPF 100avobenzone, homosalate, octisalate, octocryleneAvobenzone 30 mg/mL + 3 more ingredientsLotionTopicalWALGREEN COMPANY0363-0228
Radiance Foundation Broad Spectrum SPF 20 - Cappuccinooctinoxate, zinc oxideOctinoxate 3 g/100mL; Zinc oxide 6.8 g/100mLLiquidTopicalDistribuidora Comercial Jafra, S.A. de C.V.68828-735
Sun Bum High Performance Sunscreen Signature Clear 50 Newoctocrylene, octisalate, zinc oxideOctisalate 50 mg/mL + 2 more ingredientsLotionTopicalSun Bum, LLC69039-708
Scentual Aroma Beauty Sun Veil SPF30titanium dioxide, zinc oxideTitanium dioxide 2 g/100g; Zinc oxide 18.4 g/100gCreamTopicalLABORATOIRES DRUIDE INC71447-056
Crunchi Sunlight Tinted Sunscreen SPF 30 Mediumzinc oxideZinc oxide 940 mg/mLLiquidTopicalCrunchi, LLC.72444-0204
Farmasi BB Beauty Balm Cream SPF 15- 01 Lighttitanium dioxideTitanium dioxide 35 mg/mLCreamTopicalFarmasi US LLC74690-040
Hydrating Glow Mist SPF 50avobenzone, octisalate, octocryleneAvobenzone 3 g/100mL + 3 more ingredientsSprayTopicalNAKED SUNDAYS PTY LTD81104-102
COOLA SunBlur Makeup Mist SPF 50avobenzone, homosalate, octisalate, octocryleneOctocrylene 80 mg/mL + 3 more ingredientsSprayTopicalCOOLA LLC79753-107
spf 50 mineral powder sunscreentitanium dioxide, zinc oxideTitanium dioxide 23.9 g/100g; Zinc oxide 24.1 g/100gPowderTopicalSmalls Brand LLC DBA Roe Wellness83369-001
Odacite Nourishing Lip Serum - Jazzy Berryzinc oxideZinc oxide 132 mg/mLLotionTopicalOdacite82088-876
Visor Clear Body Oil-Free Sunscreen SPF 50avobenzone, homosalate, octisalate, octocryleneAvobenzone 30 mg/mL + 3 more ingredientsGelTopicalVISOR SKINCARE LLC85335-589
Non Tinted Mineral Sunscreen Sticktitanium dioxide, zinc oxideTitanium dioxide 40 mg/g; Zinc oxide 55 mg/gStickTopicalHirschman, Kristina85414-219
Headhunter Surf Screen SPF 50 Sunscreenzinc oxide,titanium dioxideTitanium dioxide 5.6 mg/100mL; Zinc oxide 11 mg/100mLCreamTopicalGuangzhou Tata Biotechnology Co., Ltd.84066-107
Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 Sensitiveavobenzone, homosalate, octisalate, and octocryleneAvobenzone 3 g/100mL + 3 more ingredientsLotionTopicalThe Procter & Gamble Manufacturing Company84126-232
Orlaskin Hydrating Sunscreen SPF 50octocrylene ethylhexyl methoxycinnamate ethylhexyl salicylate avobenzoneOctocrylene 10 g/100mL + 3 more ingredientsSprayTopicalGuangzhou Yapheon Health Industry Co., Ltd.87582-004
Luxe Gloss Hydrating Lip Gloss SPF 35-ICED OUToctocrylene 8%, octisalate 5%, titanium dioxide 6%, zinc oxide 8%Octocrylene .08 g/mL + 3 more ingredientsCreamTopicalLale Cosmetics LLC87911-003
UV Defense Mineral Sunscreen Tintedtitanium dioxide, zinc oxideZinc oxide 38 mg/g; Titanium dioxide 80 mg/gCreamTopicalCCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC85495-203
Reunited Lipgloss SPF 30 - WALKING ON SUNSHINEhomosalate, octocrylene, octisalateHomosalate 8 g/100mL + 2 more ingredientsLiquidTopicalPrinceville Productions, LLC, DBA Reunited Beauty87326-002
Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUShomosalate,octisalate,octocrylene,zinc oxideOctocrylene 6 g/100g + 3 more ingredientsLotionTopicalEdgewell Personal Care Brands LLC63354-682

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