BRITTO FACIAL SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream

Britto Facial Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Britto Facial Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by MR2 USA Corporation, COSMODERMA INDUSTRIA E COMERCIO LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal Display Panel - Statement of identity

Britto Facial Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)

Drug Facts Panel - Active Ingredients

Avobenzone 3.00% ----- Sunscreen

Homosalate 15.00% ----- Sunscreen

Octinoxate 7.50% ----- Sunscreen

Octisalate 5.00% ----- Sunscreen

Octocrylene 10.00% ---- Sunscreen

Oxybenzone 6.00% ----- Sunscreen

Drug Facts Panel - Purpose

Purpose: sunscreen

Drug Facts Panel - Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

Drug Facts Panel - Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Protect the product in this container from excessive heat and direct sun.

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

Questions or comments? Contact weekdays from 9AM to 5PM at 1-305-646-1169.

Package Label - Principal Display Panel

50 ml NDC: 77069-003-01

100 ml NDC: 77069-003-02

INGREDIENTS AND APPEARANCE

BRITTO FACIAL SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream

Product 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)