H-E-B Dead Sea Organics Protect and Perfect Day Broad Spectrum SPF15: Package Insert and Label Information

H-E-B DEAD SEA ORGANICS PROTECT AND PERFECT DAY BROAD SPECTRUM SPF15- avobenzone, homosalate, octisalate and octocrylene cream
Emilia Personal Care Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Avobenzone, 3.0%
Homosalate, 5.0%
Octisalate, 5.0%
Octocrylene, 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours
Use water resistant sunscreen if swimming or sweating
Children under 6 months: ask a doctor
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

Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, cyclopentasiloxane, C12-15 alkyl benzoate, glyceryl stearate, PEG-100 stearate, steareth-2, polyacrylamide, C13-14 isoparaffin, laureth-7, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, cetearyl alcohol, cetearyl glucoside, steareth-21, glycerin, caprylyl glycol, glyceryl caprylate, phenylpropanol, polymethyl methacrylate, silica, lecithin, soy isoflavones, polysorbate 80, acetyl hexapeptide-8, panthenol, persea gratissima (avocado) oil*, citrus aurantium bergamia (bergamot) fruit oil*, santalum album (sandalwood) oil*, citrus medica limonum (lemon) peel oil*, cedrus atlantica (cedarwood) bark oil*, pogostomon cablin (patchouli) oil*, myroxylon pereirae (balsam peru) oil*, dipteryx odorata bean extract*, vetiveria zizanoides root oil*, cinnamomum cassia oil*, elettaria cardamomum (cardamon) seed oil*, lavandula angustifolia (lavender) oil*, disodium EDTA, olea europaea (olive) fruit oil*, simmondsia chinensis (jojoba) seed oil*, aloe barbadensis leaf juice*, benzalkonium chloride, BHT, maris sal (dead sea mineral water), triethanolamine, opuntia streptacantha (cactus) stem extract*, phenoxyethanol.

*Organic

Adverse Event Reporting:

(866) 543-5125

Package/Label Principal Display Panel

DEAD SEA SKIN CARE by H-E-B.
PROTECT & CORRECT DAY CREAM
BROAD SPECTRUM SPF15 SUNSCREEN
Enriched with desert plants & Dead Sea minerals

1.7 FL OZ (50mL)

Dead Sea Skin Care Protect & Correct Day Cream Broad Spectrum SPF15 Sunscreen, with its unique formulation of desert plants, Dead Sea minerals and broad spectrum SPF15 sunscreen, will protect skin from harmful UV rays that cause premature skin aging. Leaves skin feeling softer, smoother with a healthy and radiant glow.

For centuries the Dead Sea, the lowest place on earth, has hosted a rich reservoir of bio-sea minerals known for their exceptional beautifying and nourishing properties.

We have taken the uniqueness of both the Dead Sea and desert plants to bring you a line of products specially formulated with time-proven goodness and health.

Desert plants: Cactus, Jojoba, Aloe Vera & Olive deeply moisturize skin and provide skin nutrition.

No animal by-products
No animal testing
pH balanced
Paraben-free
Fragrance-free

Directions for Use: Smooth over cleansed face and neck every morning. Smooth in until completely absorbed.

MADE WITH PRIDE AND CARE FOR H-E-B®,
SAN ANTONIO, TEXAS 78204
Made in Israel ZD115 1J C1

WE BELIEVE THE HIGH QUALITY OF THIS H-E-B® PRODUCT MAKES IT AN OUTSTANDING VALUE. WE HOPE YOU’LL AGREE. IF NOT, WE’LL CHEERFULLY REFUND YOUR MONEY.
THANKS FOR SHOPPING WITH US.

Carton Label
(click image for full-size original)

Carton Label

H-E-B DEAD SEA ORGANICS PROTECT AND PERFECT DAY BROAD SPECTRUM SPF15
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42421-115
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 5 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
ALKYL (C12-15) BENZOATE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
STEARETH-2
POLYACRYLAMIDE (10000 MW)
C13-14 ISOPARAFFIN
LAURETH-7
ARACHIDYL ALCOHOL
DOCOSANOL
ARACHIDYL GLUCOSIDE
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
STEARETH-21
GLYCERIN
CAPRYLYL GLYCOL
GLYCERYL CAPRYLATE
PHENYLPROPANOL
POLY(METHYL METHACRYLATE; 450000 MW)
SILICON DIOXIDE
LECITHIN, SOYBEAN
SOY ISOFLAVONES
POLYSORBATE 80
ACETYL HEXAPEPTIDE-8
PANTHENOL
AVOCADO OIL
BERGAMOT OIL
SANDALWOOD OIL
LEMON OIL
CEDRUS ATLANTICA BARK OIL
PATCHOULI OIL
BALSAM PERU OIL
DIPTERYX ODORATA SEED
VETIVER OIL
CHINESE CINNAMON OIL
CARDAMOM OIL
LAVENDER OIL
EDETATE DISODIUM
OLIVE OIL
JOJOBA OIL
ALOE VERA LEAF
BENZALKONIUM CHLORIDE
BUTYLATED HYDROXYTOLUENE
TROLAMINE
OPUNTIA STREPTACANTHA STEM
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42421-115-11 1 JAR in 1 CARTON contains a JAR
1 50 mL in 1 JAR This package is contained within the CARTON (42421-115-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/10/2014
Labeler — Emilia Personal Care Inc. (965445112)

Revised: 01/2014 Emilia Personal Care Inc.

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