Dead Sea Skin Care By H-e-b.

Dead Sea Skin Care By H-e-b.
SPL v1
SPL
SPL Set ID 263bf96a-ddb9-45cc-8c80-8f69843d55c5
Route
TOPICAL
Published
Effective Date 2014-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (5 g) Octisalate (4 g) Octocrylene
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-01-10

Description

Avobenzone, 3.0% Homosalate, 5.0% Octisalate, 5.0% Octocrylene, 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone, 3.0% Homosalate, 5.0% Octisalate, 5.0% Octocrylene, 4.0%

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.

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
Do Not Use On
  • damaged or broken skin.
Active Ingredient

Avobenzone, 3.0%

Homosalate, 5.0%

Octisalate, 5.0%

Octocrylene, 4.0%

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

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Adverse Event Reporting:

(866) 543-5125

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.

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


Structured Label Content

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.
Purpose

Sunscreen

Warnings

For external use only.

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
Do Not Use On (Do not use on)
  • damaged or broken skin.
Active Ingredient (Active ingredient)

Avobenzone, 3.0%

Homosalate, 5.0%

Octisalate, 5.0%

Octocrylene, 4.0%

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

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Adverse Event Reporting:

(866) 543-5125

Stop Use and Ask A Doctor (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.

Package/label Principal Display Panel (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


Advanced Ingredient Data


Raw Label Data

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