Label: BRITTO BODY SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 77069-002-01, 77069-002-02 - 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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- Principal Display Panel - Statement of Identity
- Drug Facts Panel - Active Ingredients
- Drug Facts Panel - Purpose
- Drug Facts Panel - Uses
- Drug Facts Panel - Warnings
- Drug Facts Panel - Directions
- Durg Facts Panel - Other Information
- Drug Facts Panel - Inactive Ingredients
- Questions and reporting of adverse events
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BRITTO BODY SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77069-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERYL PALMITATE (UNII: 6Y2XJ05B35) 1.32 g in 100 mL WATER (UNII: 059QF0KO0R) 37.05 g in 100 mL GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2.24 g in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 g in 100 mL GLYCERYL DIPALMITATE (UNII: 7775E5IR3L) 1.32 g in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g in 100 mL POLYESTER-7 (UNII: 0841698D2F) 0.6 g in 100 mL STEARIC ACID (UNII: 4ELV7Z65AP) 0.6 g in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.2 g in 100 mL ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.5 g in 100 mL METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 g in 100 mL GLYCERYL DISTEARATE (UNII: 73071MW2KM) 1.84 g in 100 mL ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) 3 g in 100 mL POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) 1 g in 100 mL NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 0.4 g in 100 mL POTASSIUM STEARATE (UNII: 17V812XK50) 0.36 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.32 g in 100 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.1 g in 100 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g in 100 mL EDETATE SODIUM (UNII: MP1J8420LU) 0.05 g in 100 mL Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77069-002-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 07/15/2020 2 NDC:77069-002-02 200 mL in 1 TUBE; Type 0: Not a Combination Product 07/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/15/2020 Labeler - MR2 USA Corporation (080950597) Establishment Name Address ID/FEI Business Operations COSMODERMA INDUSTRIA E COMERCIO LTDA 899462110 manufacture(77069-002) , pack(77069-002) , label(77069-002)
