BEYOND SPF UV DEFENSE MASQUE SPF 30- sunscreen lotion

Beyond SPF UV Defense Masque SPF 30 by

Drug Labeling and Warnings

Beyond SPF UV Defense Masque SPF 30 by is a Otc medication manufactured, distributed, or labeled by Erno Laszlo, Inc., Intercos America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient Section

Zinc oxide 20.4%

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 product keep out of eyes. Rinse with water to remove. ▪ 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.

Keep out of reach of children.

Directions

Layer after cleansing, toning, and serums, but before makeup. ▪ Apply liberally to the face and neck 15 minutes before sun exposure. ▪ Children Under 6 months of age: Ask a doctor. ▪ reapply at least every 2 hours ▪ use a water Resistant sunscreen if swimming or sweating. ▪ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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, Caprylic/Capric Triglyceride, Isononyl Isononanoate, C9-12 Alkane, Glycerin, Octyldodecanol, Polyhydroxystearic Acid, Crambe Abyssinica Seed Oil, Coco-Caprylate/Caprate, PEG-30 Dipolyhydroxystearate, Octyldodecyl Xyloside, Magnesium Sulfate, Silica, Mica, Ethylhexylglycerin, Squalane, Tocopherol, Butylene Glycol, Helianthus Annuus (Sunflower) Seed Oil, Beta-carotene, Xanthophylls, Citrullus Lanatus (Watermelon) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Citrulline, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Polygonum Cuspidatum Root Extract, Portulaca Oleracea Extract, Pelargonium Capitatum Leaf Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).

Questions?

Call 866-452-7956

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEYOND SPF UV DEFENSE MASQUE SPF 30 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57913-2804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
WATER (UNII: 059QF0KO0R)
BETA CAROTENE (UNII: 01YAE03M7J)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
MICA (UNII: V8A1AW0880)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)
PELARGONIUM CAPITATUM LEAF (UNII: 7P4L8U253X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
OCTYLDODECANOL (UNII: 461N1O614Y)
CITRULLINE (UNII: 29VT07BGDA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SQUALANE (UNII: GW89575KF9)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
CITRULLUS LANATUS VAR. LANATUS WHOLE (UNII: 3J5I6254YO)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
GLYCERIN (UNII: PDC6A3C0OX)
C18-C21 ALKANE (UNII: 33822S0M40)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LUTEIN (UNII: X72A60C9MT)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57913-2804-3	1 in 1 CARTON	05/15/2023
1		50 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 final	M020	05/15/2023

Labeler - Erno Laszlo, Inc. (098821031)

Establishment
Name	Address	ID/FEI	Business Operations
Intercos America, Inc.		080185160	label(57913-2804) , manufacture(57913-2804)