RAYDIANT BY AUSTRALIAN GOLD VITAMIN D BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Raydiant By Australian Gold by

Drug Labeling and Warnings

Raydiant By Australian Gold by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %,  Octocrylene 2.75 %, Oxybenzone 3 %

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

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

• 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 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
• Children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Cholecalciferol, Disodium EDTA, Fragrance (Parfum), Hydroxyprophyl Methylcellulose, Isopropylphtalimide, Methylisothiazolinone, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Buter, Tocopheryl Acetate, Triethanolamine, Water (Aqua) 

Other information

• protect this product from excesive heat and direct sun

Questions or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

PRINCIPAL DISPLAY PANEL- 237 mL BOTTLE

Vitamin D

Sunscreen Lotion

50

Broad

Spectrum

SPF

50

Raydiant

By Australian Gold

Water Resistant

(80 Resistant)

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

RAYDIANT BY AUSTRALIAN GOLD  VITAMIN D BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.7 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	99 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.225 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	29.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0149-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2015

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0149) , pack(58443-0149) , manufacture(58443-0149) , analysis(58443-0149)