Label: ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide lotion
- NDC Code(s): 75936-223-01, 75936-223-02
- 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 24, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Apply generously and evenly 15 minutes before sun exposure
Use a water-resistant sunscreen if swimming or sweating
Reapply 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 this risk, regularly use a
sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun
protection measures including: • limit your time in the sun, especially from 10
a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: ask a doctor. -
INACTIVE INGREDIENT
Inactive Ingredients
Water, Tetradecane, Cetearyl Nonanoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Mica, Propanediol, Disteardimonium Hectorite, Gluconolactone, Polyglyceryl-6 Polyricinoleate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Polyhydrostearic Acid, Sodium Chloride, Magnesium Sulfate, Fructose, Octyldodecyl Oleate, Tocopherol, Cocos Nucifera (Coconut) Fruit Extract, Sodium Benzoate, Iron oxides (CI 77492), Dodecane, Hexadecane, Titanium Dioxide (CI 77891), Withania Somnifera Flower Extract, Iron Oxides (CI 77491), Vaccinium Angustifolia (Blueberry) Fruit Extract, Silica, Calcium Gluconate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-223 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13 g in 100 mL Inactive Ingredients Ingredient Name Strength GLUCONOLACTONE (UNII: WQ29KQ9POT) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPANEDIOL (UNII: 5965N8W85T) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) CALCIUM GLUCONATE (UNII: SQE6VB453K) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) TETRADECANE (UNII: 03LY784Y58) ETHYLHEXYL PALMITATE (UNII: 2865993309) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) FRUCTOSE (UNII: 6YSS42VSEV) WATER (UNII: 059QF0KO0R) MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082) HEXADECANE (UNII: F8Z00SHP6Q) CETEARYL NONANOATE (UNII: F6ZWV2F361) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) COCONUT (UNII: 3RT3536DHY) SODIUM BENZOATE (UNII: OJ245FE5EU) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DODECANE (UNII: 11A386X1QH) FERRIC OXIDE RED (UNII: 1K09F3G675) LOWBUSH BLUEBERRY (UNII: G90PX41VP0) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-223-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2019 2 NDC:75936-223-02 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/30/2019 Labeler - Supergoop, LLC (117061743)
