BRIGHT FUTURE SKIN TINT SPF 25 11 IVOIRE PUR PURE- octinoxate, titanium dioxide cream

Bright future skin tint SPF 25 11 ivoire pur pure by

Drug Labeling and Warnings

Bright future skin tint SPF 25 11 ivoire pur pure by is a Otc medication manufactured, distributed, or labeled by S+. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Octinoxate 7.49%

Titanium Dioxide 2.28%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not ues 

• on damaged or broken skin

When using this product 

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• 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

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

Inactive ingredients

WATER (AQUA), CYCLOPENTASILOXANE, GLYCERIN, ISODODECANE, PENTYLENE GLYCOL, ALCOHOL, DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PEG-10 DIMETHICONE, XANTHAN GUM, SORBITAN SESQUIOLEATE, DISTEARDIMONIUM HECTORITE, PHENOXYETHANOL, ACRYLATES/DIMETHICONE COPOLYMER, ALUMINUM HYDROXIDE, ISOSTEARIC ACID, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BUTYLENE GLYCOL, POLYHYDROXYSTEARIC ACID, SODIUM MYRISTOYL GLUTAMATE, SILICA SILYLATE, PROPYLENE CARBONATE, STEARIC ACID, HYDROLYZED RICE PROTEIN, SODIUM METABISULFITE, BHT, SHEA (BUTYROSPERMUM PARKII) SEEDCAKE EXTRACT, LEMON (CITRUS LIMON) FRUIT EXTRACT, TOCOPHEROL, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499).

Package Labeling:

Inner Label

INGREDIENTS AND APPEARANCE

BRIGHT FUTURE SKIN TINT SPF 25 11 IVOIRE PUR PURE 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31720-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	22.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31720-702-17	1 in 1 CARTON	08/28/2017
1		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/28/2017

Labeler - S+ (572406531)