SUNSCREEN- octinoxate, octisalate, zinc oxide gel

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by HEB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

claims

H-E-B

Solutions

sunscreen

• With Aloe and Vitamin E
• Water Resistant (80 minutes)
• Oil Free & Wont Clog Pores
• Clear Zinc Sunscreen for Race, Nose or Ears

Active ingredient

Octinoxate 7.5%

Octisalate 5%

Zinc oxide 10%

Purpose

Sunscreen

Use

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), mdecreases 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 15 minutes before sun exposure
• reapply:
• after 80 minures 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 derease this risk,  reqularly 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 of age: Ask a doctor

other information

• protect the product from excessive heat and direct sun

inactive ingredients

water, butyloctyl salicylate, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, propanediol, triacontanyl PVP, cetearyl alcohol, PEG-100 stearate, cetearyl glucoside, glyceryl behenate, dimethicone, glycerin, PEG-150/decyl alcohol/SMDI copolymer, Aloe barbadensis leaf juice, allantoin, panthenol, tocopheryl acetate, triethoxycaprylylsilane, fragrance, phenoxyethanol, methylisothiazolinone, tetrasodium EDTA

Questions?

1-800-527-7731

Disclaimer

May stain or damage some fabrics or surfaces

MADE WITH PRIDE AND CARE FOR H-E-B

SAN ANTONIO, TN 78204

MADE IN USA WITH U.S AND FOREIGN PARTS

100% GUARANTEE

Promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.  You have our word on it

Principal panel display

H-E-B

Solutions

Sunscreen

CLEAR

ZINC

WITH OCTINOXATE & OCTISALATE

SUNSCREEN

BROAD SPECTRUM SPF 50

SPF 50

FOR FACE, NOSE OR EARS

• With Aloe and Vitamin E
• Water Resistant (80 minutes
• Oil free & Wont Clog Pores

NET WT.

1 OZ (28.3 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN 
octinoxate, octisalate, zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-726
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPANEDIOL (UNII: 5965N8W85T)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%) (UNII: VP5LS3541F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-726-10	28.3 g in 1 PACKAGE; Type 0: Not a Combination Product	06/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/06/2017

Labeler - HEB (007924756)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091520	manufacture(37808-726)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(37808-726)