DRUG FACTS:

Active Ingredients

Octinoxate 7.50%

Octisalate 3.00%

Zinc Oxide 3.00%

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.

Directions:

Apply liberally 15-minutes before sun exposure. At least every two-hours. Immediately afterswimming, sweating or towel drying.

Reapply:

Spending time in the sun increases your risk of skin cancerand early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun Protection Measures:

Limit time in the sun, especially between 10am and 2pm.
Wear long sleeve shirts, pants, hats and sunglasses.
For children under 6-months, consult a physician.

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 consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butyrosper mum Parkii (Shea) Butter,Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamido propyl Betaine, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Glycerin, Helianthus Annuus (sunflower) Oil, Glyceryl Stearate, PEG-100 Stearate, C13-14 Isoparaffin, Hydrolyzed Collagen, Isopropyl Myristate, Laureth-7, Mangifera Indica (Mango) Butter, Parfum (Fragrance), Phenoxyethanol, Polyacrylamide, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Other Information:

Protect this product from excessive heat and direct sunlight.

Package Labeling:

Label

GOLD MOUNTAIN BEAUTY COLLAGEN BROAD SPECTRUM SPF 30
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79214-157
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CUCUMBER (UNII: YY7C30VXJT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POMEGRANATE (UNII: 56687D1Z4D)
SORBITAN OLIVATE (UNII: MDL271E3GR)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79214-157-50	1 in 1 CARTON	06/10/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/10/2020

Labeler - TT Fitness, Inc (080832345)

GOLD MOUNTAIN BEAUTY Collagen Cream Broad Spectrum SPF-30