GOLD MOUNTAIN BEAUTY COLLAGEN BROAD SPECTRUM SPF 30- octinoxate, octisalate, zinc oxide cream 
TT Fitness, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GOLD MOUNTAIN BEAUTY Collagen Cream Broad Spectrum SPF-30

DRUG FACTS:

Active Ingredients

Octinoxate 7.50%

Octisalate 3.00%

Zinc Oxide 3.00%

Purpose

Sunscreen

Uses:

Directions:

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

Sun Protection Measures: 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:

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:79214-157
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79214-157-501 in 1 CARTON06/10/2020
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/10/2020
Labeler - TT Fitness, Inc (080832345)

Revised: 6/2020
Document Id: a94cb803-9a1d-3af4-e053-2995a90a7364
Set id: 617ef3af-4203-4664-b714-1b5fab2e0ee6
Version: 2
Effective Time: 20200630
 
TT Fitness, Inc