Sunfree Sunscreen

Manufacturer: Afassco | Safetec of America, Inc
Effective date: 2021-12-07
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:45:29

Label at a glance#

ProductSunfree Sunscreen

Active ingredientHomosalate, Octinoxate, Octisalate, Oxybenzone

Label structure8 sections

Indications and uses

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

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact800-441-6774

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreens

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

keep out of eyes
Rinse with water to remove

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51532-6103-1	2023-01-30	C162847	48780-1	9d75b9cf-e231-f424-e053-dadaa90a57ce	e39000cd-3397-4c1d-9fe1-0c0e305460b7
51532-6103-1	2021-12-01	C162847	48780-1	9d75b9cf-e231-f424-e053-dadaa90a57ce	e39000cd-3397-4c1d-9fe1-0c0e305460b7
51532-6103-1	2020-01-31	C162847	48780-1	9d75b9cf-e231-f424-e053-dadaa90a57ce	e39000cd-3397-4c1d-9fe1-0c0e305460b7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51532-6103-1	Sunfree Sunscreen	3.5 g in 1 PACKET	LOTION	3.5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51532-6103	SUNFREE SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [AFASSCO]	5	Legacy NDC, 1 package rows	20211208_e39000cd-3397-4c1d-9fe1-0c0e305460b7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Homosalate	ACTIVE MOIETY	V06SV4M95S	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	1
ETHYL PYRROLIDONE	INACTIVE INGREDIENT	H0229SX1CW	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
PEG-8 Dimethicone	INACTIVE INGREDIENT	GIA7T764OD	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	1
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
water	INACTIVE INGREDIENT	059QF0KO0R	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

Sunfree Sunscreen
Homosalate, Octinoxate, Octisalate, Oxybenzone
Homosalate
Octinoxate
Octisalate
Oxybenzone
cetyl alcohol
ETHYL PYRROLIDONE
propylene glycol
propylparaben
methylparaben
diazolidinyl urea
polyoxyl 40 stearate
polysorbate 60
petrolatum
water
sorbitan monostearate
edetate sodium
titanium dioxide
xanthan gum
Polyethylene Glycol 400
dimethicone
PEG-8 Dimethicone

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51532-6103	51532-6103-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Homosalate	V06SV4M95S	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Octisalate	4X49Y0596W	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
cetyl alcohol	936JST6JCN	IACT
ETHYL PYRROLIDONE	H0229SX1CW	IACT
propylene glycol	6DC9Q167V3	IACT
propylparaben	Z8IX2SC1OH	IACT
methylparaben	A2I8C7HI9T	IACT
diazolidinyl urea	H5RIZ3MPW4	IACT
polyoxyl 40 stearate	13A4J4NH9I	IACT
polysorbate 60	CAL22UVI4M	IACT
petrolatum	4T6H12BN9U	IACT
water	059QF0KO0R	IACT
sorbitan monostearate	NVZ4I0H58X	IACT
edetate sodium	MP1J8420LU	IACT
titanium dioxide	15FIX9V2JP	IACT
xanthan gum	TTV12P4NEE	IACT
Polyethylene Glycol 400	B697894SGQ	IACT
dimethicone	92RU3N3Y1O	IACT
PEG-8 Dimethicone	GIA7T764OD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 423 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	TABLET / ORAL	5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
polysorbate 60	POLYSORBATE 60	CAL22UVI4M	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAMUSCULAR	20.3 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
polysorbate 60	POLYSORBATE 60	CAL22UVI4M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c2cae822-f1d4-41f6-b32d-132e75309ca5			e39000cd-3397-4c1d-9fe1-0c0e305460b7	2021-12-07	Warnings	Exact identifier spl id: c2cae822-f1d4-41f6-b32d-132e75309ca5 spl set id: e39000cd-3397-4c1d-9fe1-0c0e305460b7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.