Label: GOLDEN AMBER SUN SHIELD BODY GLOW SPF30- avobenzone, homosalate, octisalate, octocrylene gel
- NDC Code(s): 84130-003-50
- Packager: Koco Life LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 28, 2024
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- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
• Apply generously & evenly 15 minutes before sun exposure.
REAPPLY: 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 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 • Children under 6 months: Ask a doctor
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Inactive ingredients
Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Fragrance (Parfum), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Aleurites Moluccana Seed Oil, Macadamia Ternifolia Seed Oil, Tocopheryl Acetate, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
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INGREDIENTS AND APPEARANCE
GOLDEN AMBER SUN SHIELD BODY GLOW SPF30
avobenzone, homosalate, octisalate, octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84130-003 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) KUKUI NUT OIL (UNII: TP11QR7B8R) BENZYL SALICYLATE (UNII: WAO5MNK9TU) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OCTYLDODECANOL (UNII: 461N1O614Y) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LINALOOL, (+)- (UNII: F4VNO44C09) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) AVOCADO OIL (UNII: 6VNO72PFC1) HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1) MACADAMIA OIL (UNII: 515610SU8C) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84130-003-50 150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/28/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/28/2024 Labeler - Koco Life LLC (046650159) Establishment Name Address ID/FEI Business Operations Biogenesis Inc. 069117328 manufacture(84130-003)
