FACE AND BODY SUNSCREEN- octinoxate and titanium dioxide lotion

Face and Body Sunscreen by

Drug Labeling and Warnings

Face and Body Sunscreen by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octyl Methoxycinnamate 7%

Titanium Dioxide 2.8%

Purpose

Sunscreen

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 product is swallowed, get medical help or call a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• children under 6 months: Ask a doctor
  

Other information

• protect this product from excessive heat and direct sun
• may stain fabrics
• for Lot and Expiration Date, see crimp of tube

Inactive Ingredients

Water, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Stearic acid, Ceyearyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl acrylate crosspolymer, Chlorphenesin, Triethanolamine, Lavandula Angustifolia (Lavender) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago officinalis Extract, Centaurea cyanus flower Extract, Dimethicone, Butylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Disodium EDTA, Fragrance

Package label

Face and Body Sunscreen

INGREDIENTS AND APPEARANCE

FACE AND BODY SUNSCREEN 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0081-5	100 mL in 1 TUBE; Type 0: Not a Combination Product	01/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/24/2013

Labeler - Kareway Product, Inc. (121840057)