Label: VERSED SPF 30 REPLENISHING BODY MINERAL- zinc oxide lotion
- NDC Code(s): 73690-028-01
- Packager: Offspring Beauty Co.
- 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 May 12, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- PURPOSE
- Uses
- Warnings
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Directions
- Shake well, apply liberally and evenly 15 minutes before sun exposure
- Reapply after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
- Children under 6 months of age: 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 othe sun protection measures including: limit time in sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
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INACTIVE INGREDIENT
Water/Aqua/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Vitis Vinifera (Grape) Seed Oil, Methyl Dihydroabietate, Propanediol, Potassium Cetyl Phosphate, Diheptyl Succinate, Arachidyl Alcohol, Cetyl Alcohol, Tetradecane, Sodium Stearoyl Glutamate, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Behenyl Alcohol, Sodium PCA, Theobroma Grandiflorum Seed Butter, Arachidyl Glucoside, Xanthan Gum, Sodium Gluconate, Bisabolol, Citric Acid, Caprylhydroxamic Acid, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Glycerin, Camellia Sinensis Leaf Extract, Tocopherol, Sodium Benzoate, Potassium Sorbate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VERSED SPF 30 REPLENISHING BODY MINERAL
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73690-028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.6 g in 100 mL Inactive Ingredients Ingredient Name Strength TETRADECANE (UNII: 03LY784Y58) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM BENZOATE (UNII: OJ245FE5EU) GRAPE SEED OIL (UNII: 930MLC8XGG) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DOCOSANOL (UNII: 9G1OE216XY) CETYL ALCOHOL (UNII: 936JST6JCN) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LEVOMENOL (UNII: 24WE03BX2T) SODIUM GLUCONATE (UNII: R6Q3791S76) WATER (UNII: 059QF0KO0R) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73690-028-01 177 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/01/2023 Labeler - Offspring Beauty Co. (081516405)
