Label: EVERYDAY SUNSCREEN SPF 50- avobenzone, homosalate, octinoxate, octisalate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 75936-235-01, 75936-235-03, 75936-235-04, 75936-235-05, view more75936-235-06, 75936-235-07 - Packager: Taylor James
- 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 July 6, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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 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-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
-
INACTIVE INGREDIENT
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 Rosaeodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, 1,2-hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (Sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Pentylene Glycol, Trisodium Ethylenediamene Disuccinate, Tocopheryl, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EVERYDAY SUNSCREEN SPF 50
avobenzone, homosalate, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-235 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ROSEMARY (UNII: IJ67X351P9) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) BEHENIC ACID (UNII: H390488X0A) CETYL BEHENATE (UNII: WFM51TRO3E) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) PENTYLENE GLYCOL (UNII: 50C1307PZG) TOCOPHEROL (UNII: R0ZB2556P8) PANTHENOL (UNII: WV9CM0O67Z) ISODODECANE (UNII: A8289P68Y2) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ROSEWOOD OIL (UNII: F2522O5L7B) CHLORPHENESIN (UNII: I670DAL4SZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) CETEARYL OLIVATE (UNII: 58B69Q84JO) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SORBITAN OLIVATE (UNII: MDL271E3GR) ORANGE OIL (UNII: AKN3KSD11B) EUCALYPTUS OIL (UNII: 2R04ONI662) PATCHOULI OIL (UNII: F3IN55X5PO) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) GLYCERIN (UNII: PDC6A3C0OX) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) RICE BRAN (UNII: R60QEP13IC) LAURYL LACTATE (UNII: G5SU0BFK7O) LEMON OIL (UNII: I9GRO824LL) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-235-01 71 mL in 1 TUBE; Type 0: Not a Combination Product 07/06/2018 2 NDC:75936-235-03 30 mL in 1 TUBE; Type 0: Not a Combination Product 07/06/2018 3 NDC:75936-235-04 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2018 4 NDC:75936-235-05 222 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2018 5 NDC:75936-235-06 3 mL in 1 PACKET; Type 0: Not a Combination Product 07/06/2018 6 NDC:75936-235-07 10 mL in 1 TUBE; Type 0: Not a Combination Product 07/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/06/2018 Labeler - Taylor James (033381850) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 620899877 manufacture(75936-235)
