Label: DEFENSE TOTAL HIGH PROTECTION SPF 50 NO COLOR DAILY NON-GREASY FACE PROTECTION- homosalate, octocrylene, avobenzone lotion
- NDC Code(s): 14141-140-01
- Packager: Bel Star S.A. (Colombia)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 28, 2024
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- Drug Facts
- Active ingredients
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Directions
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.
- Children under 6 months of age: ask a doctor.
- 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 value 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
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lnactive ingredients
Water, styrene/acrylates copolymer, potassium cetyl phosphate, c12·15 alkyl benzoate, cyclohexasiloxane, dimethicone, phenethyl benzoate, polymethylsilsesquioxane, propylene glycol, vp/eicosene copolymer, trimethylsiloxysilicate, phenoxyethanol, cetyl palmitate, xanthan gum, physalis angulata extract, caprylic/capric triglyceride, xanthan gum, cetearyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10·30 alkyl acrylate crosspolymer, caprylyl glycol, disodium edta, tocopheryl acetate, citric acid
- Company Information
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INGREDIENTS AND APPEARANCE
DEFENSE TOTAL HIGH PROTECTION SPF 50 NO COLOR DAILY NON-GREASY FACE PROTECTION
homosalate, octocrylene, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) XANTHAN GUM (UNII: TTV12P4NEE) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENETHYL BENZOATE (UNII: 0C143929GK) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CETYL PALMITATE (UNII: 5ZA2S6B08X) CYCLOMETHICONE 6 (UNII: XHK3U310BA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14141-140-01 30 mL in 1 BOX; Type 0: Not a Combination Product 06/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/29/2020 Labeler - Bel Star S.A. (Colombia) (880160197) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 manufacture(14141-140)