Label: BRITTO FACIAL SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 77069-003-01, 77069-003-02 - Packager: MR2 USA Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 27, 2020
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- Official Label (Printer Friendly)
- Principal Display Panel - Statement of identity
- Drug Facts Panel - Active Ingredients
- Drug Facts Panel - Purpose
- Drug Facts Panel - Uses
- Drug Facts Panel - Warnings
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Drug Facts Panel - Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply: - after 40 minutes of swimming or sweating. - immediately after towel drying. - 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.
- Drug Facts Panel - Other information
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Drug Facts Panel - Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alpha-Tocopherol Acetate, Butylated Hydroxytoluene, Ethylhexyl Stearate, Fragrance, Glycerin, Glyceryl Dipalmitate, Glyceryl Distearate, Glyceryl Palmitate, Glyceryl Stearate, Hydrolyzed Collagen, Methylparaben, Neopentyl Glycol Diheptanoate, Polyester-7, Potassium Cetyl Phosphate, Potassium Stearate, Propylene Glycol, Propylparaben, Stearic Acid, Tetrasodium EDTA, Water, Xanthan Gum.
- Questions or comments
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
BRITTO FACIAL SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77069-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2.24 g in 100 mL POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) 1 g in 100 mL POLYESTER-7 (UNII: 0841698D2F) 0.6 g in 100 mL NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 0.4 g in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1 g in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g in 100 mL EDETATE SODIUM (UNII: MP1J8420LU) 0.05 g in 100 mL WATER (UNII: 059QF0KO0R) 34.55 g in 100 mL POTASSIUM STEARATE (UNII: 17V812XK50) 0.36 g in 100 mL ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) 3 g in 100 mL METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 g in 100 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g in 100 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.1 g in 100 mL GLYCERYL DISTEARATE (UNII: 73071MW2KM) 1.84 g in 100 mL GLYCERYL PALMITATE (UNII: 6Y2XJ05B35) 1.32 g in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.2 g in 100 mL STEARIC ACID (UNII: 4ELV7Z65AP) 0.6 g in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 g in 100 mL GLYCERYL DIPALMITATE (UNII: 7775E5IR3L) 1.32 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.32 g in 100 mL PORK COLLAGEN (UNII: I8442U2G7J) 2 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77069-003-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2020 2 NDC:77069-003-02 100 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/26/2020 Labeler - MR2 USA Corporation (080950597) Establishment Name Address ID/FEI Business Operations COSMODERMA INDUSTRIA E COMERCIO LTDA 899462110 manufacture(77069-003) , pack(77069-003) , label(77069-003)
