Label: PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 44717-070-01
- Packager: Wasatch Product Development, LLC
- 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 February 6, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- shake well before use
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 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 your time in the sun, especially from 10a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
Inactive ingredients
water,cetyl palmitate, hydrated silica, acrylates/C12-22 alkyl methacrylate copolymer, caprylyl methicone, styrene/acrylates copolymer, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, polyester-8, trideceth-6, dimethicone, ethylhexyl stearate, fragrance, phenoxyethanol, dimethyl capramide, sodium polyacrylate, trimethylsiloxysilicate, xanthan gum, BHT, dipotassium glycyrrhizate, tocopheryl acetate, ethylhexylglycerin, tetrasodium glutamate diacetate
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44717-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TRIDECETH-6 (UNII: 3T5PCR2H0C) DIMETHICONE 100 (UNII: RO266O364U) PEG-100 STEARATE (UNII: YD01N1999R) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETYL PALMITATE (UNII: 5ZA2S6B08X) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44717-070-01 177 mL in 1 TUBE; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/01/2023 Labeler - Wasatch Product Development, LLC (962452533)
