Label: SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70469-142-02 - Packager: Capsule Corporation
- 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 June 12, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
- Warnings
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Directions
- Apply liberally 15-minutes before sun exposure.
- Reapply:
- At least,every 2 hours.
- Immediately after swimming, sweating or towel drying.
- SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
- Limit time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats and sunglasses.
- For children under 6 months, consult a physician.
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Inactive Ingredients
- Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E) Xanthan Gum.
- SPL UNCLASSIFIED SECTION
- Package Labeling:
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INGREDIENTS AND APPEARANCE
SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70469-142 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 60 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARROT (UNII: L56Z1JK48B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) SOYBEAN OIL (UNII: 241ATL177A) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALMOND OIL (UNII: 66YXD4DKO9) SESAME OIL (UNII: QX10HYY4QV) COCOA (UNII: D9108TZ9KG) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70469-142-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/25/2020 Labeler - Capsule Corporation (079920193)