SUNSCREEN by Shenzhen Yikai Electronic Technology Co., Ltd. SUNSCREEN cream

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Shenzhen Yikai Electronic Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 10%

Purpose

Sunscreen

Use

● 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

keep out of eyes. Rinse with waterto remove.

Stop Use

rash occurs

Keep Oot Of Reach Of Children

lf swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:
● apply generously 15 minutes before sun exposure
● reapply:
● after 80 minutes of swimming or sweating
● immediately after towel drying
● at least every 2 hours
● 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 am.-2 p.m.
● wear long-sleeved shirts, pants, hats and sunglasses
● children under 6 months of age: Ask a doctor

Other information

● protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, polymethylsilsesquioxane, glycerin, dimethicone, poly C10-30 alkyl
acrylate, styrene/acrylates copolymer, silica, caprylyl methicone,
acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate,
PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl
phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/C10-30 alkyl
acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl
carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride,
xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrin,
sodium dodecylbenzenesulfonate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83809-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW) (UNII: 3K8D4YRM4R)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-8 LAURATE (UNII: 762O8IWA10)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83809-020-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2024
2	NDC: 83809-020-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2024

Labeler - Shenzhen Yikai Electronic Technology Co., Ltd. (700426808)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Yikai Electronic Technology Co., Ltd.		700426808	manufacture(83809-020) , label(83809-020)