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

Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Skinlycious Pte Ltd, CHAKS COSMETIC DESIGN & SERVICES PTE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ondamaged or broken skin.
When using this product
Keep out of eyes.
Rinse with water to remove.

Stop use and ask a doctorif 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

WARNINGS

Product label

INGREDIENTS AND APPEARANCE

SKINLYCIOUS MULTI PROTECTION MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide , zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81574-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81574-002-01	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2021
2	NDC: 81574-002-02	5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/01/2021

Labeler - Skinlycious Pte Ltd (595402258)

Establishment
Name	Address	ID/FEI	Business Operations
CHAKS COSMETIC DESIGN & SERVICES PTE LTD		595557596	manufacture(81574-002)