Label: OUNCE BY OUNCE BROAD SPECTRUM SUNSCREEN SPF 30- zinc oxide lotion
- NDC Code(s): 75936-158-01
- Packager: Supergoop, LLC
- 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 October 27, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply generously and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- wear a water resistant sunscreen if swimming or sweating.
- 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 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-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredient Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Sodium Gluconate, Sodium Stearoyl Glutamate, Tetradecane, Tocopherol, Water, Xanthan Gum
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OUNCE BY OUNCE BROAD SPECTRUM SUNSCREEN SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.7 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO GLUCOSIDE (UNII: ICS790225B) TETRADECANE (UNII: 03LY784Y58) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) DOCOSANOL (UNII: 9G1OE216XY) COCONUT OIL (UNII: Q9L0O73W7L) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) TOCOPHEROL (UNII: R0ZB2556P8) LEVOMENOL (UNII: 24WE03BX2T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) GLYCERIN (UNII: PDC6A3C0OX) SODIUM GLUCONATE (UNII: R6Q3791S76) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-158-01 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/26/2021 Labeler - Supergoop, LLC (117061743) Registrant - Bell International Laboratories (967781555)
