Label: PURE SKIN NAKED ALL NATURAL SUNSCREEN SPF 35- zinc oxide cream
- NDC Code(s): 62800-015-01
- Packager: HNC Products Inc.
- 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 November 10, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients:
- Uses
- Warnings
-
Directions
• Apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply 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 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.
- Other Information
-
Inactive Ingredients
• Caprylic/Capric Triglyceride, Persea Gratissima (Avocado) Oil, Beeswax, Cocos Nucifera (Coconut) Oil, Soybean Glycerides, Shea Butter Unsaponificables, Tocopheryl Acetate, Bisabolol, Butyrospermum Parkii (Shea) Butter, Sesamum Indicum (Sesame) Seed Oil, Emblica Officinalis Fruit Extract, Curcumin, Copernicia Cerifera (Carnauba) Wax, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrobisdemethoxydiferuloylmethane, Potassium Cocoate, Tetrahexyldecyl Ascorbate, Fragrance.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PURE SKIN NAKED ALL NATURAL SUNSCREEN SPF 35
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62800-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength TETRAHYDRODEMETHOXYDIFERULOYLMETHANE (UNII: 44D8X9U00T) TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I) POTASSIUM COCOATE (UNII: F8U72V8ZXP) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) AVOCADO OIL (UNII: 6VNO72PFC1) YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LEVOMENOL (UNII: 24WE03BX2T) SHEA BUTTER (UNII: K49155WL9Y) SESAME OIL (UNII: QX10HYY4QV) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) CURCUMIN (UNII: IT942ZTH98) CARNAUBA WAX (UNII: R12CBM0EIZ) TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62800-015-01 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2022 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2022 12/31/2024 Labeler - HNC Products Inc. (941099533) Establishment Name Address ID/FEI Business Operations HNC Products Inc. 941099533 manufacture(62800-015) , label(62800-015) , pack(62800-015)
