PHARMAGEL - SUN THERAPE SPORT SPRAY (67879-304)

Manufacturer
PHARMAGEL INTERNATIONAL INC
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:17:08

Label at a glance#

ProductSUN THERAPE SPORT SPF-35
Active ingredientOXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTINOXATE
Label structure10 sections

Indications and uses

• Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• Apply liberally and evenly 15 minutes before sun exposure • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m.- 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Homosalate..................15%
Octinoxate.....................7.5%
Oxybenzone..................6.0%

Octocrylene................5.5%
Octisalate ...................5.0%
Avobenzone................3.0%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

WARNINGS SECTION

Warnings:
• 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 doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

• Flammable: Keep away from flame or high heat. Avoid spraying in eyes. Contents under pressure. DO not puncture or incinerate. DO not store at temperature above 120ºF.

Other Information
• Protect the product in this container from excessive heat
and direct sun

Directions For Sunscreen Use:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally and evenly 15 minutes before sun exposure
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m.- 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALCOHOL DENAT, POLYESTER-8, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ETHOXYDIGLYCOL, COCOS NUCIFERA (COCONUT) OIL, BUTYLENE GLYCOL, TRISILOXANE, FRAGRANCE (PARFUM), TOCOPHERYL ACETATE, DIMETHICONE, POLYESTER-10, PROPYLENE GLYCOL DIBENZOATE, GARDENIA TAHITENSIS (TIARE) FLOWER, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, PANTHENOL, PERSEA GRATISSIMA (AVOCADO) OIL, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DIMETHYLAMINOETHANOL TARTRATE, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CHLORPHENESIN, BENZOIC ACID, SORBIC ACID, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, LIMONIUM GERBERI EXTRACT, LECITHIN PLANKTON EXTRACT, CITRIC ACID, SODIUM BENZOATE

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 800-882-4889

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun_box_sport_final_croppedSun_box_sport_final_cropped

Sun_Sport_FINAL_croppedSun_Sport_FINAL_cropped

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67879-304-11SUN THERAPE SPORTSPF-35125 mL in 1 BOTTLE, SPRAYSPRAY1258
67879-304-51SUN THERAPE SPORTSPF-351 in 1 BOXSPRAY18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67879-304SUN THERAPE SPORT SPF-35 (HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) SPRAY [PHARMAGEL INTERNATIONAL INC]8Current NDC, Legacy NDC, 2 package rows20240815_0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX3
HOMOSALATEACTIVE INGREDIENTV06SV4M95S3
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
OCTISALATEACTIVE INGREDIENT4X49Y0596W3
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y3
AVOBENZONEACTIVE MOIETYG63QQF2NOX3
HOMOSALATEACTIVE MOIETYV06SV4M95S3
OCTINOXATEACTIVE MOIETY4Y5P7MUD513
OCTISALATEACTIVE MOIETY4X49Y0596W3
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM3
OXYBENZONEACTIVE MOIETY95OOS7VE0Y3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PK3
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC13
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM3
BORAGO OFFICINALIS SEEDINACTIVE INGREDIENT2GXJ790US03
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D33
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ3
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1X3
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L3
DEANOL BITARTRATEINACTIVE INGREDIENTD240J05W143
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
ECHINACEA ANGUSTIFOLIAINACTIVE INGREDIENTVB06AV5US83
GARDENIA TAITENSIS FLOWERINACTIVE INGREDIENTT0OCU8201Y3
HYDRASTIS CANADENSIS WHOLEINACTIVE INGREDIENTR763EBH88T3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM623
LIMONIUM GERBERI WHOLEINACTIVE INGREDIENT2J5K7YCF9F3
MACADAMIA OILINACTIVE INGREDIENT515610SU8C3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3
OCTYL ACRYLATEINACTIVE INGREDIENTEJN94319DN3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
POLYESTER-10INACTIVE INGREDIENT212N9O2MMZ3
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138P3
PROPYLENE GLYCOL DIBENZOATEINACTIVE INGREDIENTEQY32Z1AN43
ROSA CANINA FRUITINACTIVE INGREDIENT3TNW8D08V33
SIMMONDSIA CHINENSIS SEEDINACTIVE INGREDIENTD24K2Q1F6H3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B3
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ3
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0G3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67879-30467879-304-11, 67879-304-51

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Source Document#

Source XML · Source PDF

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 3 · 135 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
21 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii+route
15 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
18 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
15 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
21 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
15 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route
15 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii+route
12 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
18 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
21 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BLOTION / TOPICAL714 mgExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
18 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
18 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BSYSTEM / TOPICAL1720 mgExact identifier — unii+route
15 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route
15 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUN THERAPE SPORT SPF-35HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONEPHARMAGEL INTERNATIONAL INC0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d92024-08-13WarningsExact identifier
ndc (package): 67879-304-11
ndc (package): 67879-304-51
ndc (product): 67879-304
ndc11 (package): 67879030411
ndc11 (package): 67879030451
spl id: 1f947c4a-043e-710e-e063-6394a90aa155
spl set id: 0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d9

Reported adverse events (FAERS/openFDA)#

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