Label: INVISIBLE SUNSCREEN SPF 40- homosalate, octisalate, avobenzone, octocrylene cream
- NDC Code(s): 84426-001-01
- Packager: PARTICLE AESTHETIC SCIENCE LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 18, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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Directions
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- 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 of age: Ask a doctor
- Other information
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INACTIVE INGREDIENT
Inactive Ingredients:
Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INVISIBLE SUNSCREEN SPF 40
homosalate, octisalate, avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84426-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mg in 100 mg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.6 mg in 100 mg AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 100 mg Inactive Ingredients Ingredient Name Strength DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM BENZOATE (UNII: OJ245FE5EU) PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) ISOMALT (UNII: S870P55O2W) WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TOCOPHEROL (UNII: R0ZB2556P8) ISODODECANE (UNII: A8289P68Y2) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) SESAME SEED (UNII: 7Y1255HVXR) VITIS VINIFERA FRUIT RIND (UNII: 653OHN32Q1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84426-001-01 1 in 1 CARTON 06/28/2024 1 50 mg 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 Drug M020 06/28/2024 Labeler - PARTICLE AESTHETIC SCIENCE LTD (521782995) Establishment Name Address ID/FEI Business Operations COSMAX USA 010990210 manufacture(84426-001)
