POLYGLUTAMIC ACID DEWY SUNSCREEN SPF 30- avobenzone, ensulizole, octisalate, octocrylene lotion

SPF 30 Daily Sunscreen by

Drug Labeling and Warnings

SPF 30 Daily Sunscreen by is a Otc medication manufactured, distributed, or labeled by Brand Evangelists for Beauty Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE 3%

ENSULIZOLE 3%

OCTISALATE 5%

OCTOCRYLENE 10%

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

External use only

• DO NOT USE ON DAMAGED OR BROKEN SKIN.
• WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVVE.
• 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

• apply liberally and evenly 15 minutes before sun exposure
• 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 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”
• Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

AQUA (WATER), GLYCERIN, COCO-CAPRYLATE/CAPRATE, TRIHEPTANOIN, SACCHAROMYCES FERMENT, CETEARYL ALCOHOL, GLYCERYL STEARATE SE, TROMETHAMINE, GLYCERYL CAPRYLATE, PROPANEDIOL, C9-12 ALKANE, DILINOLEIC ACID/BUTANEDIOL COPOLYMER, SODIUM STEAROYL GLUTAMATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DIMETHICONE, SQUALANE, HECTORITE, LAUROYL LYSINE, HYDROXYETHYLCELLULOSE, CAPRYLHYDROXAMIC ACID, DIMETHICONAL, POLYSORBATE 60, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ORYZA SATIVA (PURPLE RICE) HULL EXTRACT, CASTOR/IPDI COPOLYMER, PHENOXYETHANOL, POLYGLUTAMIC ACID, SORBITAN ISOSTEARATE, CAMELLIA SINENSIS (PURPLE TEA) LEAF EXTRACT, IPOMOEA BATATAS (PURPLE SWEET POTATO) ROOT EXTRACT, HYDROXYACETOPHENONE, SODIUM BENZOATE, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, LACTOBACILLUS FERMENT LYSATE, SACCHAROMYCES LYSATE.

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun

QUESTIONS OR COMMENTS?

Call toll free (833) 981-2335

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POLYGLUTAMIC ACID DEWY SUNSCREEN  SPF 30
avobenzone, ensulizole, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81136-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPHORONE DIISOCYANATE (UNII: 43B0856528)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TROMETHAMINE (UNII: 023C2WHX2V)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PROPANEDIOL (UNII: 5965N8W85T)
COCONUT ALKANES (UNII: 1E5KJY107T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
HECTORITE (UNII: 08X4KI73EZ)
LACTOBACILLUS KEFIRI (UNII: QD244ZH5CA)
LAUROYL LYSINE (UNII: 113171Q70B)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
RICE GERM (UNII: 7N2B70SFEZ)
CASTOR OIL (UNII: D5340Y2I9G)
IPOMOEA BATATAS WHOLE (UNII: 46B7278T57)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81136-101-50	1 in 1 CARTON	01/17/2023
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 not final	part352	01/17/2023

Labeler - Brand Evangelists for Beauty Ltd. (222990724)