EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT- avobenzone, homosalate, octinoxate, octisalate cream

Drug Labeling and Warnings

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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

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

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

Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 50

Water & Sweat resistant (80 minutes)

2.4 fl oz/ 71 ml

INGREDIENTS AND APPEARANCE

EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT 
avobenzone, homosalate, octinoxate, octisalate cream

Product 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)