Label: CALIFORNIA MANGO SPF-30 SUNSCREEN- avobenzone, octisalate, octocrylene liquid
- NDC Code(s): 83453-405-00
- Packager: CALMANGO, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
-
Directions:
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply:
- After 80 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 the risk, regularly use a suncreen with 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-sleeved shirts, pants, hats, and sunglasses.
- Other Information:
-
Inactive Ingredients:
Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranante) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
CALIFORNIA MANGO SPF-30 SUNSCREEN
avobenzone, octisalate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83453-405 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength KIWI FRUIT (UNII: 71ES77LGJC) ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SAFFLOWER (UNII: 4VBL71TY4Y) COCONUT OIL (UNII: Q9L0O73W7L) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) FLAX SEED (UNII: 4110YT348C) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83453-405-00 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2023 Labeler - CALMANGO, INC (193808441)
