Label: FACE AND BODY MINERAL SPF NON-TINTED- titanium dioxide, zinc oxide aerosol, foam
- NDC Code(s): 81535-211-01
- Packager: Flawless Skin Care, LLC (dba Abby Skin Clinic)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE:
-
USES:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- WARNINGS:
-
DIRECTIONS:
- Shake well before using.
- Push nozzle up to release safety tab.
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
-
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am-2 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
-
INACTIVE INGREDIENTS:
Butyloctyl Salicylate, Cl2-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth 20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Water
- OTHER INFORMATION:
-
Principal Display Panel - 100 g Can Label
ABBY SKIN CARE
ABBY ODIAMAR PACLIBAR
FACE & BODY
MINERAL SPF
NON-TINTEDOil Free Mousse Sunscreen
broad spectrum SPF 30
water resistant (40 mins)- Great for all skin types
- Photo-stable will not degrade in sunlight
- FREE of chemical sunscreen filters, dyes,
fragrances, oils and preservatives - Reef friendly
- non-comedogenic
3.5 oz | 100 g
-
INGREDIENTS AND APPEARANCE
FACE AND BODY MINERAL SPF NON-TINTED
titanium dioxide, zinc oxide aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81535-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 30 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 100 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) POLYSORBATE 80 (UNII: 6OZP39ZG8H) 1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81535-211-01 100 g in 1 CAN; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/24/2018 Labeler - Flawless Skin Care, LLC (dba Abby Skin Clinic) (031934930) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(81535-211) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(81535-211) Establishment Name Address ID/FEI Business Operations Keystone Industries 014769301 PACK(81535-211)