Label: HAWAIIAN SOL NATURAL SUNSCREEN SPF-30- zinc oxide solution
- NDC Code(s): 82520-263-00
- Packager: Caribbean Sol International, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Drug Facts
- Active Ingredient
- Uses
- Warnings
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Directions-------SHAKE WELL--------
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 SPE of 15 or higher and other sun protection measures including: Sun Protection Measures -
- 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.
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Inactive Ingredients:
Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Hydroxyethylcellu-lose, Laminaria (Algae) Extract, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Tocopherol (Vitamin E), Tridecyl Salicylate, Xanthan Gum.
- Other information
- Package Labeling:
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INGREDIENTS AND APPEARANCE
HAWAIIAN SOL NATURAL SUNSCREEN SPF-30
zinc oxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82520-263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 160 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCONUT (UNII: 3RT3536DHY) COCONUT OIL (UNII: Q9L0O73W7L) CARROT (UNII: L56Z1JK48B) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DODECANE (UNII: 11A386X1QH) GLYCERYL LAURATE (UNII: Y98611C087) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) MANGO (UNII: I629I3NR86) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) TOCOPHEROL (UNII: R0ZB2556P8) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82520-263-00 177.44 mL in 1 CAN; Type 0: Not a Combination Product 01/24/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/24/2022 Labeler - Caribbean Sol International, LLC (116857302)