SEPHORA 8HR MATTIFYING MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 20- avobenzone, octinoxate, octocrylene cream

Sephora 8hr Mattifying Moisturizer Sunscreen Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Sephora 8hr Mattifying Moisturizer Sunscreen Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by S+. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.00%

Octinoxate 7.50%

Octocrylene 2.37%

Purpose

Sunsceen

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 use

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 Poison Control Center right away.

Directions

for sunscreen use

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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, DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, GLYCERIN, POLYSORBATE 20, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DIMETHICONE CROSSPOLYMER, SORBITOL, SQUALANE, BUTYLENE GLYCOL, PANTHENOL, POLYSORBATE 60, POMEGRANATE (PUMICA GRANATUM) EXTRACT, TOCOPHERYL ACETATE, SENNA (CASSIA ANGUSTIFOLIA) SEED POLYSACCHARIDE, ENANTIA CHLORANTHA BARK EXTRACT, OLEANOLIC ACID, CAPRYLYL GLYCOL, PHENOXYETHANOL, FRAGRANCE

Pakage Labeling:

INGREDIENTS AND APPEARANCE

SEPHORA 8HR MATTIFYING MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 20 
avobenzone, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31720-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITOL (UNII: 506T60A25R)
SQUALANE (UNII: GW89575KF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31720-202-10	1 in 1 CARTON	11/19/2012
1		50 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 final	part352	11/19/2012

Labeler - S+ (572406531)