NDC | 42421-115-11 |
Set ID | 263bf96a-ddb9-45cc-8c80-8f69843d55c5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Emilia Personal Care Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredient
- Purpose
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Uses
- •
- helps prevent sunburn
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- 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
- Do not use on
- When using this product
- Stop use and ask a doctor
- Keep Out of Reach of Children
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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
- •
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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
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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:
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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 minerals1.7 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
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- No animal testing
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- pH balanced
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- 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 C1WE 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
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INGREDIENTS AND APPEARANCE
H-E-B DEAD SEA ORGANICS PROTECT AND PERFECT DAY BROAD SPECTRUM SPF15
avobenzone, homosalate, octisalate, octocrylene creamProduct 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)