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
- 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 June 20, 2023
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- 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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- Product Packaging
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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 final 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)
