Label: EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT- avobenzone, homosalate, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-215-01, 75936-215-02, 75936-215-03, 75936-215-04, view more75936-215-05, 75936-215-06 - Packager: Taylor James
- Category: HUMAN OTC DRUG LABEL
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 February 19, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Apply liberally 15 minutes before sun exposure
Reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skincancer 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-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Inactive Ingredients
Water, Isododecane, Polyester-8, Glycerin, Cetyl Alcohol, Potassium Cetyl Phosphate, Acrylates Copolymer, Oryza Sativa (Rice) Bran Extract, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Roseadora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (Sunflower) Extract, Behenix Acid, Cetyl Behenate, Isostearyl Isostearate, Pentylene Glycol, Trisodium Ethylenediamine Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT
avobenzone, homosalate, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-215 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) ALLANTOIN (UNII: 344S277G0Z) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PANTHENOL (UNII: WV9CM0O67Z) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) RICE BRAN (UNII: R60QEP13IC) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) LAURYL LACTATE (UNII: G5SU0BFK7O) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) CHLORPHENESIN (UNII: I670DAL4SZ) EUCALYPTUS OIL (UNII: 2R04ONI662) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL BEHENATE (UNII: WFM51TRO3E) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) PENTYLENE GLYCOL (UNII: 50C1307PZG) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) LEMON OIL (UNII: I9GRO824LL) XANTHAN GUM (UNII: TTV12P4NEE) ROSEMARY (UNII: IJ67X351P9) ISODODECANE (UNII: A8289P68Y2) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ROSEWOOD OIL (UNII: F2522O5L7B) ORANGE OIL (UNII: AKN3KSD11B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PATCHOULI OIL (UNII: F3IN55X5PO) BEHENIC ACID (UNII: H390488X0A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-215-01 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2019 2 NDC:75936-215-02 222 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2019 3 NDC:75936-215-03 71 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2019 4 NDC:75936-215-04 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2019 5 NDC:75936-215-05 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2019 6 NDC:75936-215-06 3 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/19/2019 Labeler - Taylor James (033381850) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 620899877 manufacture(75936-215)
