Label: SUN THERAPE FACE SPF-35- octinoxate, octisalate, oxybenzone, avobenzone lotion
- NDC Code(s): 67879-302-11, 67879-302-51
- Packager: PHARMAGEL INTERNATIONAL INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 7, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
-
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, 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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN THERAPE FACE SPF-35
octinoxate, octisalate, oxybenzone, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67879-302 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) STEARIC ACID (UNII: 4ELV7Z65AP) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDROXYETHYL CELLULOSE (2000 MPA.S 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) 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) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) UNDECYLENOYL GLYCINE (UNII: 4D20464K2J) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) GOLDENSEAL (UNII: ZW3Z11D0JV) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) GINKGO (UNII: 19FUJ2C58T) LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F) SODIUM BENZOATE (UNII: OJ245FE5EU) LACTIC ACID (UNII: 33X04XA5AT) UNDECYLENIC ACID (UNII: K3D86KJ24N) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CHONDRUS CRISPUS (UNII: OQS23HUA1X) 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:67879-302-51 1 in 1 BOX 06/18/2015 1 NDC:67879-302-11 100 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 Drug M020 06/18/2015 Labeler - PHARMAGEL INTERNATIONAL INC (603215182) Registrant - PHARMAGEL INTERNATIONAL INC (603215182)
