LOREAL PARIS INFALLIBLE PROGLOW BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate liquid

LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 3.2%

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

Flammable until dry.

Do not use near fire, flame or heat.

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 a Poison Control Center right away.

Directions

For sunscreen use:

● shake well

● 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, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, dimethicone, magnesium sulfate, ethylhexyl hydroxystearate, talc, silica, PEG/PPG/polybutylene glycol-8/5/3 glycerin, disodium stearoyl glutamate, dimethicone/polyglycerin-3 crosspolymer, polymethyl methacrylate, tocopheryl acetate, aluminum hydroxide, magnesium stearate, silica silylate, dipropylene glycol, alumina, BHT, sodium citrate, tocopherol, isopropyl alcohol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

Questions or comments?

1-800-322-2036

Monday - Friday

(10 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS INFALLIBLE PROGLOW BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	32 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-14 DIMETHICONE (UNII: G7DL1Y4G26)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM STEARATE (UNII: 70097M6I30)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-043-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/26/2016	02/26/2016
2	NDC: 49967-043-02	30 mL in 1 TUBE; Type 0: Not a Combination Product	02/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/26/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	manufacture(49967-043) , pack(49967-043)