Sunscreen

Manufacturer: Total Resources International | Safetec of America, Inc.
Effective date: 2024-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:49:08

Label at a glance#

ProductSunscreen

Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE

Label structure7 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate (6.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (5.0%)

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

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

keep out of eyes
rinse with water to remove

Keep out of reach of children.

if swallowed, conatct a poison control center right away

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product

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, contact a poison control center right away

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL – packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunscreen Lotion
SPF 30

1.5 g. (0.0570 oz.)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55550-102-01	2023-01-26	C162847	48780-1	ba0f9c33-2171-a910-e053-dadaa90a0b85	Sunscreen
55550-102-01	2021-01-29	C162847	48780-1	ba0f9c33-2171-a910-e053-dadaa90a0b85	Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55550-102-01	Sunscreen	1.5 g in 1 PACKET	LOTION	1.5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55550-102	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	4	Current NDC, Legacy NDC, 1 package rows	20241228_7d4f820d-e154-428e-89c2-2e26e088ceef.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
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	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
povidone K30	INACTIVE INGREDIENT	U725QWY32X	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 · 22 matching rows.

Sunscreen
Homosalate, Octinoxate, Octisalate, Oxybenzone
CETYL ALCOHOL
POVIDONE K30
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
HOMOSALATE
OCTINOXATE
OCTISALATE
OXYBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55550-102	55550-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETYL ALCOHOL	936JST6JCN	IACT
POVIDONE K30	U725QWY32X	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
HOMOSALATE	V06SV4M95S	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB

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 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	AEROSOL, FOAM / TOPICAL	1.9 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
polysorbate 60	POLYSORBATE 60	CAL22UVI4M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	LOTION / TOPICAL		89 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	AEROSOL, FOAM / TOPICAL	1.9 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
polysorbate 60	POLYSORBATE 60	CAL22UVI4M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	LOTION / TOPICAL		89 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route+dosage form 2 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
Sunscreen	HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Total Resources International	7d4f820d-e154-428e-89c2-2e26e088ceef	2024-12-20	Warnings	Exact identifier ndc (package): 55550-102-01 ndc (product): 55550-102 ndc11 (package): 55550010201 spl id: 1a647efd-f17c-44f1-ab72-974603f42bf7 spl set id: 7d4f820d-e154-428e-89c2-2e26e088ceef

Reported adverse events (FAERS/openFDA)#

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