BEYOND SPF UV DEFENSE MASQUE SPF 30- sunscreen lotion 
Erno Laszlo, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Tube LabelCarton Label

BEYOND SPF UV DEFENSE MASQUE SPF 30 
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57913-2804
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2804-31 in 1 CARTON05/15/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/15/2023
Labeler - Erno Laszlo, Inc. (098821031)
Establishment
NameAddressID/FEIBusiness Operations
Intercos America, Inc.080185160label(57913-2804) , manufacture(57913-2804)

Revised: 2/2023
Document Id: eb8c999d-4ff8-7844-e053-2995a90aaea5
Set id: eb8c999d-4ff7-7844-e053-2995a90aaea5
Version: 1
Effective Time: 20230227
 
Erno Laszlo, Inc.