WESTERN FAMILY SPF 15- avobenzone, homosalate, octisalate, octocrylene lotion

Western FAMILY by

Drug Labeling and Warnings

Western FAMILY by is a Otc medication manufactured, distributed, or labeled by WESTERN FAMILY FOODS, INC., Playtex Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone   2.0%

Homosalate   10.0%

Octisalate       5.0%

Octocrylene    5.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decrease 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 a Poison Control Center right away. May stain some fabrics.

Directions

• apply liberally 15 minutes before sun exposure
• reapply
• after 80 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 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-sleeve shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

Inactive ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Carbomer, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Chlorphenesin, Fragrance.

Other Information

•  protect this product from excessive heat and direct sun
  

Principal Display Panel

WESTERN FAMILY

Broad Spectrum

SPF 15

sunscreen lotion

UVA/UVB protection

moisturizing with vitamin e

water resistant

(80 minutes)

10 FL OZ (295 mL)

Questions or comments?

Call 1-503-639-6300

INGREDIENTS AND APPEARANCE

WESTERN FAMILY  SPF 15
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SORBITOL (UNII: 506T60A25R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-017-57	290 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/07/2014

Labeler - WESTERN FAMILY FOODS, INC. (192166072)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc		963501502	manufacture(55312-017)