YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30- octisalate, octinoxate, oxybenzone, avobenzone cream

YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by Skin Ai, LLC, Columbia Cosmetic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Avobenzone 3.0% - Sunscreen

Octinoxate 7.5% - Sunscreen

Octisalate 5.0% - Sunscreen

Oxybenzone 4.0% - 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

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

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.
use a water-resistant sunscreen if swimming or sweating.
reapply at least every 2 hours.
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 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-sleeve shirts, pants, hats, and sunglasses.

Inactive ingredients

Water (Aqua), Isoeicosane, Potassium Cetyl Phosphate, Glycerin, Cetearyl Alcohol, Cetyl Dimethicone, Dimethicone, Ethylhexyl Methoxycrylene, Silica, Sorbitan Sesquioleate, Hydroxyethylacrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Isohexadecane, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Camellia Sinensis (White Tea) Leaf Extract, Punica Granatum (Pomegranate) Extract, May Contain: Titanium Dioxide CI 77891, Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499. Rev. 2

Other information

protect this product from excessive heat and direct sun.

PURPOSE

For external use only.

PRINCIPAL DISPLAY PANEL

TINTED MOISTURIZER
HYDRATING & ANTI-AGING

BROAD-SPECTRUM SPF 30

40ml (1.35 fl. oz)

INGREDIENTS AND APPEARANCE

YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30 
octisalate, octinoxate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84229-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PUNICA GRANATUM LEAF (UNII: O9486I5JXI)
ISOHEXADECANE (UNII: 918X1OUF1E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
IRON OXIDES (UNII: 1K09F3G675)
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SILICA (UNII: ETJ7Z6XBU4)
ISOEICOSANE (UNII: AR294KAG3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%) (UNII: 5F4963KLHS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84229-1001-1	1 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2025

Labeler - Skin Ai, LLC (003716972)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetic		068267863	manufacture(84229-1001)