SEACRET CC CREAM COLOR CORRECTOR BROAD SPECTRUM SPF 15 - DARK- octinoxate, titanium dioxide cream

Seacret by

Drug Labeling and Warnings

Seacret by is a Otc medication manufactured, distributed, or labeled by SEACRET SPA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Octinoxate 4.0%

Titanium Dioxide 4.6%

PURPOSE

Purpose

Sunscreen

Sunscreen

INDICATIONS & USAGE

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

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 occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

-Apply liberally 15 minutes before sun exposure.

-Reapply at least every 2 hours.

-Use water-resistant sunscreen if swimming or sweating.

-Children under 6 months of age: 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 10 a.m. - 2 p.m.

-wear long-sleeved shirts, pants, hats and sunglasses.

STORAGE AND HANDLING

Other information - protect this product in this container

from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients water, potassium cetyl phosphate,

cyclopentasilozane, talc, glyceryl myristate, butylene glycol,

propanediol, behenyl alcohol, C12-15 alkyl benzoate,

caprylic/capric triglyceride, isohexadecane, isononyl

isononanoate, boron nitride, microcrystalline cellulose,

cellulose gum, glycerin, sodium lactate, lactic acid,

tea-lactate, serine, urea, sorbitol, sodium chloride, allantoin,

phenoxyethanol, ethylhexylglycerin, nylon-12, ammonium

acryloyldimethyltaurate/VP copolymer, fragrance,

triethanolamine, disodium EDTA, tocopheryl acetate

(vitamin E), maris sal (sea salt), hyaluronic acid, iron oxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEACRET  CC CREAM COLOR CORRECTOR BROAD SPECTRUM SPF 15 - DARK
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69915-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g  in 40 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.84 g  in 40 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
GLYCERYL MYRISTATE (UNII: 6992Y81827)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MALONDIALDEHYDE (UNII: 4Y8F71G49Q)
DOCOSANOL (UNII: 9G1OE216XY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRICAPRYLIN (UNII: 6P92858988)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BORON NITRIDE (UNII: 2U4T60A6YD)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)
SERINE (UNII: 452VLY9402)
UREA (UNII: 8W8T17847W)
SORBITOL (UNII: 506T60A25R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NYLON-12 (UNII: 446U8J075B)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SEA SALT (UNII: 87GE52P74G)
HYALURONIC ACID (UNII: S270N0TRQY)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69915-006-01	1 in 1 CARTON
1		40 g 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	07/13/2015

Labeler - SEACRET SPA LLC (363790846)