H-E-B DEAD SEA ORGANICS PROTECT AND PERFECT DAY BROAD SPECTRUM SPF15- avobenzone, homosalate, octisalate, octocrylene cream

H-E-B Dead Sea Organics Protect and Perfect Day Broad Spectrum SPF15 by

Drug Labeling and Warnings

H-E-B Dead Sea Organics Protect and Perfect Day Broad Spectrum SPF15 by is a Otc medication manufactured, distributed, or labeled by Emilia Personal Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARETH-2 (UNII: V56DFE46J5)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PHENYLPROPANOL (UNII: 0F897O3O4M)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOY ISOFLAVONES (UNII: 71B37NR06D)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
PANTHENOL (UNII: WV9CM0O67Z)
AVOCADO OIL (UNII: 6VNO72PFC1)
BERGAMOT OIL (UNII: 39W1PKE3JI)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
LEMON OIL (UNII: I9GRO824LL)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
PATCHOULI OIL (UNII: F3IN55X5PO)
BALSAM PERU OIL (UNII: DIK0395679)
DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)
VETIVER OIL (UNII: 9M9P32M01L)
CHINESE CINNAMON OIL (UNII: A4WO0626T5)
CARDAMOM OIL (UNII: JM0KJ091HZ)
LAVENDER OIL (UNII: ZBP1YXW0H8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TROLAMINE (UNII: 9O3K93S3TK)
OPUNTIA STREPTACANTHA STEM (UNII: 3TF9Z1U73O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42421-115-11	1 in 1 CARTON
1		50 mL in 1 JAR

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)