DEAD SEA ESSENTIALS ALGAE SMOOTHING AND PROTECTING DAY BROAD SPECTRUM SPF 20- avobenzone, homosalate, octisalate, and octocrylene cream

DEAD SEA ESSENTIALS by

Drug Labeling and Warnings

DEAD SEA ESSENTIALS by is a Otc medication manufactured, distributed, or labeled by AHAVA Dead Sea Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone [3%]	sunscreens
Homosalate [7%]	sunscreens
Octisalate [5%]	sunscreens
Octocrylene [2.7%]	sunscreens

Uses

• helps prevent sunburn

Warnings

For External Use Only

When using this product keep out of eyes. Rinse with water to remove

Stop use and consult a doctor if rash or irritation develops and lasts

Do not use on damaged or broken skin

Keep out of reach of children. If swallowed, get medical attention or contact a Poison Control Center right away

Directions

• apply liberally and evenly to clean face 15 minutes before sun exposure
• apply daily for a clearer, brighter complexion
• children under 6 months of age: 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients

AQUA (MINERAL SPRING WATER), BUTYLOCTYL SALICYLATE, DIMETHICONE, GLYCERIN, OCTYLDODECYL NEOPENTANOATE, NIACINAMIDE, ASCORBYL GLUCOSIDE (VITAMIN C DERIVATIVE), STYRENE/ACRYLATES COPOLYMER, C12-15 ALKYL BENZOATE, STEARYL ALCOHOL, PEG-100 STEARATE, GLYCERYL STEARATE, SODIUM CITRATE, POTASSIUM CETYL PHOSPHATE, HYDROGENATED OLIVE OIL CETYL ESTERS, PHENOXYETHANOL, HYDROGENATED PALM GLYCERIDES, AMINOMETHYL PROPANOL, CETEARYL ALCOHOL, BENZOTRIAZOLYL DODECYL P-CRESOL, SALICYLIC ACID, TOCOPHERYL (VITAMIN E) ACETATE, PARFUM (FRAGRANCE), XANTHAN GUM, ETHYLHEXYLGLYCERIN, HYDROGENATED POLYDECENE, DIISOBUTYL ADIPATE, BUTYLENE GLYCOL, CITRIC ACID, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, GLYCINE SOJA (SOYBEAN) OIL, HYDROGENATED VEGETABLE GLYCERIDES CITRATE, BETA-SITOSTEROL, ASCORBYL PALMITATE, PROPYLENE GLYCOL, LECITHIN, SODIUM BENZOATE, POTASSIUM SORBATE, SODIUM HYDROXIDE, LACTIC ACID, COMMIPHORA ABYSSINICA RESIN EXTRACT, OPUNTIA FICUS-INDICA FRUIT EXTRACT, SQUALENE (PHYTOSQUALENE), PORPHYRA UMBILICALIS EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, ZIZYPHUS JUJUBA FRUIT EXTRACT, PSEUDOALTEROMONAS FERMENT EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHEROL (VITAMIN E), ASCORBIC ACID, RUMEX OCCIDENTALIS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHOENIX DACTYLIFERA (DATE) FRUIT EXTRACT, DUNALIELLA SALINA (DEAD SEA ALGA) EXTRACT, MARIS AQUA (DEAD SEA WATER/OSMOTER).

Other information

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

Questions or comments

Call toll free 1-800-366-7254

SPL UNCLASSIFIED SECTION

Manufactured by AHAVA Dead Sea Laboratories, Dead Sea, Israel, 8698000

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

DEAD SEA
essentials®

DEAD SEA
SCIENCE & NATURE

DEAD SEA ALGAE

SMOOTHING & PROTECTING
DAY CREAM SPF20
Broad Spectrum

Minerals and Algae to smooth fine lines
and protect your skin's aging

Registered by the VEGAN Society

INGREDIENTS AND APPEARANCE

DEAD SEA ESSENTIALS   ALGAE SMOOTHING AND PROTECTING DAY BROAD SPECTRUM SPF 20
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-293
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	70 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
NIACINAMIDE (UNII: 25X51I8RD4)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED OLIVE OIL CETYL ESTERS (UNII: AUR5S128JM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
SALICYLIC ACID (UNII: O414PZ4LPZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SOYBEAN OIL (UNII: 241ATL177A)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
COMMIPHORA MADAGASCARIENSIS RESIN (UNII: WCM0X628RY)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
JUJUBE FRUIT (UNII: G55HNL2C70)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DATE (UNII: H3O7QI5HY7)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-293-24	1 in 1 CARTON	05/20/2020
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/20/2020

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)