Label: SKIN PROUD SERIOUS SHADE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene emulsion
- NDC Code(s): 82803-001-01
- Packager: Lottie London Limited
- 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 October 26, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply generously and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
- 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.
- For use on children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
Aqua (Water, Eau), Cocoglycerides, Silica, Cetyl Dimethicone, Peg-15 Cocamine, Stearyl Behenate, Glycerin, C12-15 Alkyl Benzoate, Peg-40 Stearate, Polyhydroxystearic Acid, Phenoxyethanol, Tocopheryl Acetate, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Parfum (Fragrance), Disodium Edta, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Malpighia Punicifolia Fruit Extract, Spirulina Platensis Powder, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Sodium Hydroxide, Ceramide Np, Limonene, Hexyl Cinnamal, Linalool, Geraniol, Citral.
- Company Information
- Product Packaging
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INGREDIENTS AND APPEARANCE
SKIN PROUD SERIOUS SHADE SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82803-001 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) PEG-15 COCAMINE (UNII: 8L6LB12TSJ) PEG-40 STEARATE (UNII: ECU18C66Q7) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALOE VERA LEAF (UNII: ZY81Z83H0X) CERAMIDE NP (UNII: 4370DF050B) SODIUM HYDROXIDE (UNII: 55X04QC32I) GERANIOL (UNII: L837108USY) CITRAL (UNII: T7EU0O9VPP) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) LIMONENE, (+)- (UNII: GFD7C86Q1W) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) LINALOOL, (+)- (UNII: F4VNO44C09) STEARYL BEHENATE (UNII: A68S9UI39D) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M) GLYCERIN (UNII: PDC6A3C0OX) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO-GLYCERIDES (UNII: ISE9I7DNUG) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82803-001-01 1 in 1 CARTON 02/27/2023 1 40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/27/2023 Labeler - Lottie London Limited (220466583)
