SUN THERAPE FACE

Manufacturer
PHARMAGEL INTERNATIONAL INC
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:56:47

Label at a glance#

ProductSUN THERAPE FACE SPF-35
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE
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

Octinoxate............................7.5%

Octisalate.............................5.0%

Oxybenzone..........................3.0%

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

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

WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, GLYCERYL STEARATE, PEG-100

STEARATE, CETEARYL ALCOHOL, STEARIC ACID, DIMETHICONE, FRAGRANCE (PARFUM),

PHENOXYETHANOL, MYRISTYL MYRISTATE, CAPRYLYL GLYCOL, HYDROXYETHYLCELLULOSE,

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, ALLANTOIN, HEXYLENE

GLYCOL, MYRISTYL LAURATE, PANTHENOL, TETRASODIUM EDTA, AMINOMETHYL PROPANOL, GLYCERIN,

GLYCOLIC ACID, BUTYLENE GLYCOL, MORUS ALBA LEAF EXTRACT, BORAGO OFFICINALIS SEED OIL,

BUTYLOCTYL SALICYLATE, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE

KOJIC ACID, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL PHOSPHATE,

NIACIN, PERSEA GRATISSIMA (AVOCADO) OIL, PHYLLANTHUS EMBLICA FRUIT EXRACT, ROSA CANINA

(ROSE HIP) FRUIT EXTRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE,

UNDECYLENOYL PHENYLALANINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCYRRHIZA GLABRA

(LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CYPERUS ROTUNDUS

ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA)

EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED

EXTRACT, GINKGO BILOBA LEAF EXTRACT, LIMONIUM GERBERI EXTRACT, SODIUM BENZOATE, LACTIC ACID,

UNDECYLENIC ACID, POTASSIUM SORBATE, YELLOW 6 (CI 15985), LECITHIN, PLANKTON EXTRACT,

CHLORPHENESIN, RED 40 (CI 16035), BENZOIC ACID, SORBIC ACID

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 800-882-4889

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Face-UCFace-UC

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PK2
ALLANTOININACTIVE INGREDIENT344S277G0Z2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q2
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC12
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
BORAGE OILINACTIVE INGREDIENTF8XAG1755S2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D32
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ2
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1X2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L2
CYPERUS ROTUNDUS TUBERINACTIVE INGREDIENT4B51SRR9592
DEANOL BITARTRATEINACTIVE INGREDIENTD240J05W142
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
ECHINACEA ANGUSTIFOLIAINACTIVE INGREDIENTVB06AV5US82
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU2
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933092
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
GINKGOINACTIVE INGREDIENT19FUJ2C58T2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38S2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H2
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JV2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J2
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N2
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN162
KOJIC ACIDINACTIVE INGREDIENT6K23F1TT522
LACTIC ACIDINACTIVE INGREDIENT33X04XA5AT2
LIMONIUM GERBERI WHOLEINACTIVE INGREDIENT2J5K7YCF9F2
MACADAMIA OILINACTIVE INGREDIENT515610SU8C2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M52
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
MORUS ALBA LEAFINACTIVE INGREDIENTM8YIA49Q2P2
MYRISTYL LAURATEINACTIVE INGREDIENT58U0NZN2BT2
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DY2
NIACININACTIVE INGREDIENT2679MF687A2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PHYLLANTHUS EMBLICA FRUITINACTIVE INGREDIENTYLX4CW25762
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
ROSA CANINA FRUITINACTIVE INGREDIENT3TNW8D08V32
SIMMONDSIA CHINENSIS SEEDINACTIVE INGREDIENTD24K2Q1F6H2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
UNDECYLENIC ACIDINACTIVE INGREDIENTK3D86KJ24N2
UNDECYLENOYL GLYCINEINACTIVE INGREDIENT4D20464K2J2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 2 · 65 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67879-30267879-302-11, 67879-302-51

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 63 matching rows.

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 · 466 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii candidate
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CHONDRUS CRISPUSCHONDRUS CRISPUSOQS23HUA1XLOTION / TOPICALNAExact identifier — unii candidate
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATSOLUTION / ORAL192 mgExact identifier — unii candidate
18 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8ELIXIR / ORAL5.4 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
15 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
HYDROGENATED SOYBEAN LECITHINHYDROGENATED SOYBEAN LECITHINH1109Z9J4NCREAM / TOPICAL1.5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATINJECTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
18 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION/ DROPS / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 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
1fd49ec0-d316-f4bc-e063-6394a90a622535fdca00-7ef2-4129-9122-0bc7058acb502024-08-16WarningsExact identifier
spl set id: 35fdca00-7ef2-4129-9122-0bc7058acb50

Reported adverse events (FAERS/openFDA)#

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