SUNFREE SUNSCREEN- homosalate, octinoxate, octisalate, oxybenzone lotion 
Afassco

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)

Purpose

Sunscreens

Uses

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

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

Principal Display Panel - Packet Label

res

SUNFREE SUNSCREEN 
homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-6103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate6 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51532-6103-13.5 g in 1 PACKET; Type 0: Not a Combination Product10/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2014
Labeler - Afassco (609982723)
Registrant - Safetec of America, Inc (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc 874965262MANUFACTURE(51532-6103)

Revised: 12/2021
Document Id: c2cae822-f1d4-41f6-b32d-132e75309ca5
Set id: e39000cd-3397-4c1d-9fe1-0c0e305460b7
Version: 5
Effective Time: 20211207
 
Afassco