EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate cream

Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

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 casused by the sun

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is 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 gerenously and evenly 15 minutes before sun exsposure
• 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 a broad spectrum SPF value 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, Polyester-8, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Campstris/Aleurites Fordi Oil Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Roseodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethyhexylglycerin, Eucaluptyus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamine Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid

PRINCIPAL DISPLAY PANEL

Everyday Sunscreen with Sunflower Extract

Broad Spectrum SPF 30

2.4 fl. oz. 71 ml

INGREDIENTS AND APPEARANCE

EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-210
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
BEHENIC ACID (UNII: H390488X0A)
CETYL BEHENATE (UNII: WFM51TRO3E)
ISOSTEARYL STEARATE (UNII: E08UTG6X4W)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
ROSEWOOD OIL (UNII: F2522O5L7B)
CHLORPHENESIN (UNII: I670DAL4SZ)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISODODECANE (UNII: A8289P68Y2)
LAURYL LACTATE (UNII: G5SU0BFK7O)
CETYL ALCOHOL (UNII: 936JST6JCN)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
RICE BRAN (UNII: R60QEP13IC)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-210-01	71 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2019
2	NDC: 75936-210-02	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/12/2019

Labeler - TAYLOR JAMES LTD (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company		620899877	manufacture(75936-210)