BLACK RICE PLATINUM ABSOLUTE YOUTH SPF 15- avobenzone, ensulizole, octinoxate, and octocrylene cream

Black Rice Platinum Absolute Youth SPF 15 by

Drug Labeling and Warnings

Black Rice Platinum Absolute Youth SPF 15 by is a Otc medication manufactured, distributed, or labeled by EBPD LLC, ORLANE S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Ensulizole 2.0%	Sunscreen
Octinoxate 2.0 %	Sunscreen
Octocrylene 5.0%	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 at least every 2 hours
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with 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.
• Children under 6 months of age: Ask a doctor.

Other information

• Protect the product in this container from excessive heat and sun.

Inactive ingredients

WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, C12-15 ALKYL BENZOATE, CETEARYL OLIVATE, PENTAERYTHRITYL DISTEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, DIMETHICONE, PVP/HEXADECENE COPOLYMER, ORYZA SATIVA (RICE) BRAN EXTRACT, HYDROLYZED RICE PROTEIN, PANTHENOL, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, EUTERPA OLERACEA FRUIT EXTRACT, XANTHAN GUM, CARBOMER, ETHYLHEXYL PALMITATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, SODIUM HYALURONATE, DIAZOLIDINYL UREA, SODIUM HYDROXIDE, FRAGRANCE, BHT, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, CITRONELLOL, BUTYLPHENYL METHYLPROPIONAL, LINALOOL, HEXYL CINNAMAL, LIMONENE, ALPHA-ISOMETHYL IONONE, EUGENOL.

SPL UNCLASSIFIED SECTION

Distributed in USA Distr.EBPD LLC
300 Kennedy Drive, Sayreville N.J 08872

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

BLACK RICE PLATINUM
100% ITALIAN RICE EXTRACTS
BLACK VENERE RICE

HAND CREAM ABSOLUTE YOUTH
Global Age-Defying Beauty Solutions

Sun Screen
Broad Spectrum
SPF 15

PERLIER

3.3 FL OZ (100mL)

INGREDIENTS AND APPEARANCE

BLACK RICE PLATINUM ABSOLUTE YOUTH SPF 15 
avobenzone, ensulizole, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59582-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	20 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	20 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Tricaprylin (UNII: 6P92858988)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetearyl Olivate (UNII: 58B69Q84JO)
Pentaerythritol (UNII: SU420W1S6N)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Sorbitan Olivate (UNII: MDL271E3GR)
Sheanut Oil (UNII: O88E196QRF)
Dimethicone (UNII: 92RU3N3Y1O)
Hexadecyl Povidone (4 Hexadecyl Branches/Repeat) (UNII: AG75W62QYU)
Rice Bran (UNII: R60QEP13IC)
Panthenol (UNII: WV9CM0O67Z)
Olea Europaea Leaf (UNII: MJ95C3OH47)
Acai (UNII: 46AM2VJ0AW)
Xanthan Gum (UNII: TTV12P4NEE)
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)
Ethylhexyl Palmitate (UNII: 2865993309)
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)
Butylene Glycol (UNII: 3XUS85K0RA)
Hyaluronate Sodium (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59582-015-01	1 in 1 CARTON
1		100 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/15/2013

Labeler - EBPD LLC (077477227)

Establishment
Name	Address	ID/FEI	Business Operations
ORLANE S.A.		578687469	MANUFACTURE(59582-015)