Label: BEYOND SPF UV DEFENSE MASQUE SPF 30- sunscreen lotion
- NDC Code(s): 57913-2804-3
- Packager: Erno Laszlo, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 27, 2023
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- Active Ingredient Section
- Purpose
- Uses
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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.
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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
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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).
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INGREDIENTS AND APPEARANCE
BEYOND SPF UV DEFENSE MASQUE SPF 30
sunscreen lotionProduct 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)
