ALWAYS LIQUID FOUNDATION MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 - SHELL- homosalate, octisalate, zinc oxide liquid

Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Shell by

Drug Labeling and Warnings

Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Shell by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Homosalate 4.25%

Octisalate 4.75%

Zinc Oxide 6.75%

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 productkeep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Shake well
• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a 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 this product from excessive heat and direct sun

Inactive Ingredients.

Water/Aqua, Hydroxypropylcocoate PEG-8 Dimethicone, Petroleum Distillates, Dimethicone, Caprylyl Methicone, Kaolin, C12-15 Alkyl Benzoate, Phenyl Trimethicone, Silica, Disteardimonium Hectorite, Glycerin, Sodium Chloride, Lecithin, Triethoxycaprylylsilane, Propylene Carbonate, Dimethicone Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Silica Dimethyl Silylate, Ethylhexylglycerin, Hexylene Glycol, Methicone, Titanium Dioxide, Iron Oxides

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Product label

INGREDIENTS AND APPEARANCE

ALWAYS LIQUID FOUNDATION MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 - SHELL 
homosalate, octisalate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-809
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHICONE (20 CST) (UNII: 6777U11MKT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-809-01	1 in 1 CARTON	01/19/2024
1		30 mL in 1 TUBE; 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	01/19/2024

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)