STOKODERM SUN PROTECT 30 PURE- suncreen cream

Stokoderm Sun Protect 30 PURE by

Drug Labeling and Warnings

Stokoderm Sun Protect 30 PURE by is a Otc medication manufactured, distributed, or labeled by SC Johnson Professional USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

AVOBENZONE 3.0%
HOMOSALATE 10.0%
OCTINOXATE 7.5%
OCTISALATE 5.0%
OXYBENZONE 4.0%

Purpose

Sunscreen

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

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.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

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

Directions

apply liberally to cool dry skin 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 am - 2 pm
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: ask a doctor

Inactive ingredients

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, BENZYL ALCOHOL, CARBOMER, CETYL ALCOHOL, DEA-CETYL PHOSPHATE, DISODIUM EDTA, HYDROGENATED POLYISOBUTENE, STEARIC ACID, TRIETHANOLAMINE, WATER (AQUA)

Other information

Protect the product in this container from excessive heat and direct sun.

Questions or comments?

1-800-248-7190 Mon-Fri 8 am to 5 pm ET

PRINCIPAL DISPLAY PANEL

deb stoko

Stokoderm®
Sun Protect 30 PURE
EN Sunscreen with Broad Spectrum UV Protection
Non-Greasy / Perfume-Free / Water-Resistant (80 minutes)
ES Protector solar de amplio esprectro con proteccion UV
Non-grasa / Sin perfume / Resistente al aqua (80 minutos)
UVA UVB SPF 30
SUNSCREEN
Broad Spectrum SPF 30
Stock #:
SUN1L
deb
Distributed by:
Deb USA, Inc.
Charlotte, NC 28217
1-800-248-7190
www.debgroup.com
Made in USA
DCN8391/0115
33.8 fl oz (1 L)

INGREDIENTS AND APPEARANCE

STOKODERM SUN PROTECT 30 PURE 
suncreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-031
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
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 934 (UNII: Z135WT9208)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL PHOSPHATE (UNII: VT07D6X67O)
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-031-39	30 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2015
2	NDC: 11084-031-10	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2015
3	NDC: 11084-031-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2015

Labeler - Deb USA, Inc. (607378015)

Registrant - Deb USA, Inc. (078805627)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-031)