Label: TROPICAL OTTERS GLITTER SUNSCREEN SPF-50 - SUGAR SPARKLE- homosalate, octisalate, octocrylene, zinc oxide cream
- NDC Code(s): 84164-460-00
- Packager: 6174 INDUSTRIES, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 6, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
-
Directions
- Apply liberally15 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 this risk, regularly use a sunscreen 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:
Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Cosmetic Glitter (Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane 33), Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, FD&C Blue #1, FD&C Red #40
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
TROPICAL OTTERS GLITTER SUNSCREEN SPF-50 - SUGAR SPARKLE
homosalate, octisalate, octocrylene, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84164-460 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 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 ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SAFFLOWER (UNII: 4VBL71TY4Y) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCONUT OIL (UNII: Q9L0O73W7L) CARROT (UNII: L56Z1JK48B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) SORBITAN OLIVATE (UNII: MDL271E3GR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CORN (UNII: 0N8672707O) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84164-460-00 133 mL in 1 TUBE; Type 0: Not a Combination Product 03/04/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/04/2024 Labeler - 6174 INDUSTRIES, LLC (110191799)
