![EVERYDAY SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [TAYLOR JAMES]](https://medic.hrt.org//dailymed/images/705bf411-a4b1-d07f-e053-2991aa0ad1e1/06.05.18 Everyday Sunscreen SPF 50 inner.jpg)
![EVERYDAY SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [TAYLOR JAMES]](https://medic.hrt.org//dailymed/images/705bf411-a4b1-d07f-e053-2991aa0ad1e1/06.05.18 Everyday Sunscreen SPF 50.jpg)
| NDC | 75936-235-01, 75936-235-03, 75936-235-04, 75936-235-05, 75936-235-06, 75936-235-07 |
| Set ID | 705bf411-a4b1-d07f-e053-2991aa0ad1e1 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Taylor James |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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)
