GOLD DYNAMICS SKIN BOOSTING MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, oxybenzone, octisalate, octinoxate cream

Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 2.5%, Oxybenzone 2%, Octisalate 4%, Octinoxate 7.5%

Purpose

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

Warning

For external use only
Do not useon damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove.
Stop use and ask a doctorif rash occurs
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Direction

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 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 your time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

KEEP OUT OF REACH OF CHILDREN

Inactive ingredients

Water, Cetearyl Alcohol, Glycerin, Stearyl Stearate, Myristyl Myristate, Sodium PCA, Pentylene Glycol, Garcinia Indica Seed Butter, Ceteareth-20, Bis-Diglyceryl Polyacyladipate-2, Cyclomethicone, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Castanea Sativa (Chestnut) Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chondrus Crispus Extract, Soy Isoflavones, Dimethiconol, Gold, Ceramide NG, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, C12-15 Alkyl Benzoate, Panthenol, Biosaccharide Gum-4, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Trisodium EDTA, Smithsonite Extract, Tribehenin, Alcohol, PEG-4 Laurate, PEG-4 Dilaurate, Polysorbate 80, Lecithin, Iodopropynyl Butylcarbamate, PEG-4, PEG-10 Phytosterol, Palmitoyl Hexapeptide-12, Fragrance, Synthetic Fluorphlogopite, Titanium Dioxide, Iron Oxides, Tin Oxide

Other information

Protect this product from excessive heat and direct sun

Product label

INGREDIENTS AND APPEARANCE

GOLD DYNAMICS SKIN BOOSTING MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, oxybenzone, octisalate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-099
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL STEARATE (UNII: 5WX2EGD0DK)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
CYCLOMETHICONE (UNII: NMQ347994Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
PAPAYA (UNII: KU94FIY6JB)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
SOY ISOFLAVONES (UNII: 71B37NR06D)
DIMETHICONE (UNII: 92RU3N3Y1O)
GOLD (UNII: 79Y1949PYO)
CERAMIDE NG (UNII: C04977SRJ5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PANTHENOL (UNII: WV9CM0O67Z)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
ALCOHOL (UNII: 3K9958V90M)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
PEG-4 DILAURATE (UNII: KCR71CW036)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)
STANNOUS OXIDE (UNII: JB2MV9I3LS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-099-01	1 in 1 CARTON	04/13/2022
1		200 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 68828-099-02	1 in 1 CARTON	04/13/2022
2		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/13/2022

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-099)