Label: PURE HAVEN BODY SPF 30- titanium dioxide, zinc oxide cream
- NDC Code(s): 71355-349-00
- Packager: Pure haven, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses:
- Warnings: For external use
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Directions:
- Apply liberally 15-minutes before sun exposure.
- Reapply:
- At least every two-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this riks, 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, cansult a physician.
SUN PROTECTION MEASURES. -
Other ingredients
Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tree) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita, Glycerin, Glyceryl Stearate, Heliathus Annuus (Sunflower) Oil, Leuconostoc/ Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum
- Other Information:
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
PURE HAVEN BODY SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71355-349 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) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETEARYL OLIVATE (UNII: 58B69Q84JO) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) ALMOND (UNII: 3Z252A2K9G) SESAME OIL (UNII: QX10HYY4QV) SORBITAN OLIVATE (UNII: MDL271E3GR) COCOA (UNII: D9108TZ9KG) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71355-349-00 90 mL in 1 TUBE; Type 0: Not a Combination Product 07/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/01/2018 Labeler - Pure haven, LLC (080591039)
