EVERYDAY SUNSCREEN SPF 50- avobenzone, homosalate, octinoxate, octisalate cream

Everyday Sunscreen SPF 50 by

Drug Labeling and Warnings

Everyday Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Taylor James, Cosway Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscree

PURPOSE

Uses Helps Prevent Sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of Skin cancer and early skin aging caused by the sun

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

For External use only

Do not use on damaged or broken skin

When using this product, Keep out of eyes. Rinse with water to remove

If swallowed, get medical help or contact a Poison Control Center right away

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

Everyday Sunscreen with Sunflower Extract

Broad Spectrum SPF 50

2.4 fl. oz./ 71 ml

INGREDIENTS AND APPEARANCE

EVERYDAY SUNSCREEN SPF 50 
avobenzone, homosalate, octinoxate, octisalate cream

Product 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)