SKINLYCIOUS MULTI PROTECTION MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide , zinc oxide cream 
Skinlycious Pte Ltd

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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Drug Facts

Active ingredients

Titanium Dioxide 3.3%

Zinc Oxide 13.8%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• provides high protection against 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 or irritation develops and lasts.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Apply to all skin exposed to the sun.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months: ask a doctor.
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 10a.m.-2p.m. 
- wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Hydrogenated Polydecene, Butylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogen Dimethicone, Ethylene/Acrylic Acid Copolymer, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Olea Europaea Leaf Extract, Phenoxyethanol, Sodium Chloride, Aluminium Hydroxide, Allantoin, Sodium Citrate, Ethylhexylglycerin.

Other information

• protect this product from excessive heat and direct sun

Questions or comments

(302) 291-7376

Product label

image description

SKINLYCIOUS MULTI PROTECTION MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide , zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81574-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81574-002-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2021
2NDC:81574-002-025 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2021
Labeler - Skinlycious Pte Ltd (595402258)
Establishment
NameAddressID/FEIBusiness Operations
CHAKS COSMETIC DESIGN & SERVICES PTE LTD595557596manufacture(81574-002)

Revised: 1/2023
Document Id: f2780f75-d066-1af7-e053-2995a90af23d
Set id: e0ad02c3-f5ed-4b72-ba96-07d9c489a4ea
Version: 2
Effective Time: 20230117
 
Skinlycious Pte Ltd