Label: SARANGHAE LETS GET PHYSICAL SHEER UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion
- NDC Code(s): 83206-0100-1
- Packager: TOOCOO MEDIA INC.
- 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 February 12, 2023
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- Active Ingredients
- Uses
- Warnings
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Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor -
Inactive ingredients
Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methylheptyl Isostearate, Niacinamide, Nylon-12, Methylpropanediol, Silica, Coco-Caprylate, Sodium Chloride, Polyglyceryl-2 Dipolyhdroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Phenylpropanol, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide
- Other Information
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INGREDIENTS AND APPEARANCE
SARANGHAE LETS GET PHYSICAL SHEER UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83206-0100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) CANOLA OIL (UNII: 331KBJ17RK) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83206-0100-1 1 in 1 CARTON 02/12/2023 1 50 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/12/2023 Labeler - TOOCOO MEDIA INC. (203011457)