SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30- octocrylene, octinoxate, oxybenzone, avobenzone cream

Sunscreen Face and Body Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Sunscreen Face and Body Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Sothys Paris, Cofran International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octocrylene 10%
Octyl methoxycinnamate 7.5%
Oxybenzone 5%
Avobenzone 3%

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 use

• on damaged or broken skin
• in the eye contour

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
• 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

Acrylamide/sodium acryloyldimethyltaurate copolymer, Ammonium acryloyldimethyltaurate/ VP copolymer, Aqua (Water), Butylene glycol, C12-15 alkyl benzoate, Caprylhydroxamic acid, Caprylyl glycol, Dicaprylyl carbonate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate, Helianthus annuus (Sunflower) seed extract, Isohexadecane, Parfum (Fragrance), PEG-100 stearate, Phenoxyethanol, Polymethyl methacrylate, Polysorbate 80, Potassium Cetyl phosphate, Sorbitan oleate, Sorbitan stearate, Tocopherol, Tocopheryl acetate, VP/eicosene
copolymer

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 
octocrylene, octinoxate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51683-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER SEED (UNII: R9N3379M4Z)
ISOHEXADECANE (UNII: 918X1OUF1E)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51683-002-01	1 in 1 BOX	06/08/2016
1		125 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	06/08/2016

Labeler - Sothys Paris (271112281)

Establishment
Name	Address	ID/FEI	Business Operations
Cofran International Corp		122716855	repack(51683-002)