Label: SUN THERAPE FACE AND BODY SPF-35- avobenzone, octinoxate, octisalate, oxybenzone lotion
- Label RSS
- Share
- NDC Code(s): 67879-309-12, 67879-309-51
- Packager: PHARMAGEL INTERNATIONAL INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 27, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
Directions For Sunscreen Use:
• 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:
WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, DIMETHICONE, PALMITIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, STEARIC ACID, 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, CAMELLIA SINENSIS (BLACK TEA) LEAF EXTRACT, ELETTARIA CARDAMOMUM SEED EXTRACT, JASMINUM OFFICINALE FLOWER/LEAF EXTRACT, ROSE EXTRACT, MYRISTIC ACID, 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, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, UNDECYLENOYL PHENYLALANINE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ARACHIDIC ACID, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, BHT, ABIES BALSAMEA (BALSAM CANADA) EXTRACT, CANANGA ODORATA (YLANG) FLOWER EXTRACT, COFFEA ARABICA LEAF/SEED EXTRACT, CUCUMIS MELO CANTALUPENSIS FRUIT EXTRACT, FERULA GALBANIFLUA GUM EXTRACT, HYACINTHUS ORIENTALUS (HYACINTHUS) FLOWER EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ROSA CANINA (ROSE HIP) FRUIT 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
- OTHER INFORMATION
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUN THERAPE FACE AND BODY SPF-35
avobenzone, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67879-309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) PALMITIC ACID (UNII: 2V16EO95H1) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARIC ACID (UNII: 4ELV7Z65AP) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALLANTOIN (UNII: 344S277G0Z) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MYRISTYL LAURATE (UNII: 58U0NZN2BT) PANTHENOL (UNII: WV9CM0O67Z) EDETATE SODIUM (UNII: MP1J8420LU) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) GLYCERIN (UNII: PDC6A3C0OX) GLYCOLIC ACID (UNII: 0WT12SX38S) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MORUS ALBA LEAF (UNII: M8YIA49Q2P) TEA LEAF (UNII: GH42T47V24) CARDAMOM (UNII: 8BC4CUT4JL) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) MYRISTIC ACID (UNII: 0I3V7S25AW) BORAGE OIL (UNII: F8XAG1755S) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCONUT OIL (UNII: Q9L0O73W7L) DEANOL BITARTRATE (UNII: D240J05W14) KOJIC ACID (UNII: 6K23F1TT52) MACADAMIA OIL (UNII: 515610SU8C) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) NIACIN (UNII: 2679MF687A) AVOCADO OIL (UNII: 6VNO72PFC1) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) UNDECYLENOYL PHENYLALANINE (UNII: 271P08C6OD) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ARACHIDIC ACID (UNII: PQB8MJD4RB) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BALSAM FIR LEAFY TWIG (UNII: H1TFV1454Z) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) ARABICA COFFEE BEAN (UNII: 3SW678MX72) CANTALOUPE (UNII: 8QF5D5H6UH) GALBANUM (UNII: C690YC9N2Z) HYACINTHUS ORIENTALIS FLOWER (UNII: Y740K1LEA3) APPLE (UNII: B423VGH5S9) CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) GOLDENSEAL (UNII: ZW3Z11D0JV) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) GINKGO (UNII: 19FUJ2C58T) LIMONIUM GERBERI FLOWERING TOP (UNII: V4O4C05BJ2) SODIUM BENZOATE (UNII: OJ245FE5EU) LACTIC ACID (UNII: 33X04XA5AT) UNDECYLENIC ACID (UNII: K3D86KJ24N) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) CHLORPHENESIN (UNII: I670DAL4SZ) FD&C RED NO. 40 (UNII: WZB9127XOA) BENZOIC ACID (UNII: 8SKN0B0MIM) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67879-309-51 1 in 1 BOX 06/10/2016 1 NDC:67879-309-12 125 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/18/2015 Labeler - PHARMAGEL INTERNATIONAL INC (603215182) Registrant - PHARMAGEL INTERNATIONAL INC (603215182)
