Label: TROPIC SUN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 58443-0397-4 - Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 5, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
-
Directions
apply liberally 15 minutes before sun exposure
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 a 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor
- Other information
-
Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water
- Questions or comments?
- Tropic Sun SPF 50 Sunscreen Lotion Kids
-
INGREDIENTS AND APPEARANCE
TROPIC SUN SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0397 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99.2 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.6 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 49.6 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.76 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) COCOA BUTTER (UNII: 512OYT1CRR) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (White to Off White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0397-4 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/05/2021 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0397) , label(58443-0397) , analysis(58443-0397) , pack(58443-0397)