FACIAL SKIN SHIELD BROAD SPECTRUM SPF50 PLUS- avobenzone, ensulizole, homosalate, octisalate, and octocrylene cream

Facial Skin Shield Broad Spectrum SPF50 Plus by

Drug Labeling and Warnings

Facial Skin Shield Broad Spectrum SPF50 Plus 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 2.84%	sunscreen
Ensulizole 3%	sunscreen
Homosalate 7.3%	sunscreen
Octisalate 5%	sunscreen
Octocrylene 9.89%	sunscreen

Uses

• helps prevent sunburn

Warnings

For External Use Only

Do not use on damaged or broken skin.

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

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

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

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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.

Inactive Ingredients

Aqua (Mineral Spring Water), Carthamus Tinctorius (Safflower) Oleosomes, C15-19 Alkane, Glycerin, Propanediol, Dimethyl Capramide, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Tapioca Starch, Cellulose Acetate, Coco-Caprylate/ Caprate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Aminomethyl Propanol, PEG-40 Stearate, Phenoxyethanol, Hydrogenated Palm Glycerides, Parfum (Fragrance), Tetramethyl Acetyloctahydronaphthalenes, Geraniol, Citronellol, Illite, Disodium Cetearyl Sulfosuccinate, Sodium Hydroxide, Xanthan Gum, Gluconolactone, Chlorphenesin, Sodium Citrate, 1,2-Hexanediol, Caprylyl Glycol, Didecyldimonium Chloride, Sodium Benzoate, Potassium Sorbate, Citric Acid, Biosaccharide Gum-4, Allantoin, Mentha Piperita (Peppermint) Leaf Juice, Maris Aqua (Dead Sea Water/Osmoter).

Other information

Protect this product from excessive heat and direct sun.

Questions or comments

Call toll free 1-800-366-7254

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

AHAVA

SPF 50+

Facial Skin Shield
Broad Specrtum
SPF 50+

PA++++

BROAD SPECTRUM UVB UVA

SUN

INGREDIENTS AND APPEARANCE

FACIAL SKIN SHIELD BROAD SPECTRUM SPF50 PLUS 
avobenzone, ensulizole, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0284 g  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.03 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.073 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0989 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
C15-19 ALKANE (UNII: CI87N1IM01)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LEDIKITE (UNII: D7BC5B0F46)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
ALLANTOIN (UNII: 344S277G0Z)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-302-24	1 in 1 CARTON	01/01/2025
1		50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	01/01/2025

Labeler - AHAVA - Dead Sea Laboratories Ltd (600056907)