Label: SURYA NATURAL MINERAL SUNSCREEN- zinc oxide cream
- NDC Code(s): 71987-009-01
- Packager: Hale Cosmeceuticals
- 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
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- Drug Facts
- Active Ingredients:
- Uses
- Warnings
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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
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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.
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INGREDIENTS AND APPEARANCE
SURYA NATURAL MINERAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71987-009 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 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) TETRAHYDRODEMETHOXYDIFERULOYLMETHANE (UNII: 44D8X9U00T) TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I) POTASSIUM COCOATE (UNII: F8U72V8ZXP) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71987-009-01 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2022 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2022 12/31/2024 Labeler - Hale Cosmeceuticals (168405822)
