SUNFREE SUNSCREEN- homosalate, octinoxate, octisalate, oxybenzone lotion

Sunfree Sunscreen by

Drug Labeling and Warnings

Sunfree Sunscreen by is a Otc medication manufactured, distributed, or labeled by Afassco, Safetec of America, Inc . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)

Purpose

Sunscreens

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• for skin highly sensitive to sunburn

Warnings

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. Stop use and ask a doctor if rash occurs.

When using this product

• keep out of eyes
• Rinse with water to remove

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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: ask a doctor
• protect from excessive heat and direct sun

Inactive ingredients

cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

Principal Display Panel - Packet Label

SUNFREE™
SUNSCREEN

SPF 30 PABA Free

Net contents 3.5g (1/8 oz.)

Mfd for:

Afassco::®

Minden, NV 89423

800-441-6774

INGREDIENTS AND APPEARANCE

SUNFREE SUNSCREEN 
homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-6103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	6 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
cetyl alcohol (UNII: 936JST6JCN)
ETHYL PYRROLIDONE (UNII: H0229SX1CW)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
diazolidinyl urea (UNII: H5RIZ3MPW4)
polyoxyl 40 stearate (UNII: 13A4J4NH9I)
polysorbate 60 (UNII: CAL22UVI4M)
petrolatum (UNII: 4T6H12BN9U)
water (UNII: 059QF0KO0R)
sorbitan monostearate (UNII: NVZ4I0H58X)
edetate sodium (UNII: MP1J8420LU)
titanium dioxide (UNII: 15FIX9V2JP)
xanthan gum (UNII: TTV12P4NEE)
Polyethylene Glycol 400 (UNII: B697894SGQ)
dimethicone (UNII: 92RU3N3Y1O)
PEG-8 Dimethicone (UNII: GIA7T764OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51532-6103-1	3.5 g in 1 PACKET; 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	10/01/2014

Labeler - Afassco (609982723)

Registrant - Safetec of America, Inc (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc		874965262	MANUFACTURE(51532-6103)