Label: MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50- zinc oxide lotion
- NDC Code(s): 73054-107-11
- Packager: SOLARA SUNCARE, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 3, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- shake or knead before each use
- apply generously and evenly 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use asunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
INACTIVE INGREDIENTS
Water (Aqua), Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Microcrystalline Cellulose, Malpighia Glabra (Acerola) Fruit Extract, Sodium Hyaluronate, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, Cetyl Alcohol, Bisabolol, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Cellulose Gum, Coco-Glucoside, Polyhydroxystearic Acid, Ethylhexylglycerin, Phenoxyethanol, Sodium Gluconate, Citric Acid
- OTHER INFORMATION
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73054-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) COCOA BUTTER (UNII: 512OYT1CRR) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) LEVOMENOL (UNII: 24WE03BX2T) TOCOPHEROL (UNII: R0ZB2556P8) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) COCO GLUCOSIDE (UNII: ICS790225B) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM GLUCONATE (UNII: R6Q3791S76) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73054-107-11 1 in 1 BOX 10/17/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/17/2021 Labeler - SOLARA SUNCARE, INC. (040998319)
