SPF 15 ANTI-SHINE MOISTURIZING- octinoxate and octocrylene lotion

SPF 15 Anti-shine moisturizing by

Drug Labeling and Warnings

SPF 15 Anti-shine moisturizing by is a Otc medication manufactured, distributed, or labeled by Laboratoire Dr Renaud Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate (Octyl Methoxycinnamate) 7.77% w/w and Octocrylene 0.10% w/w

INACTIVE INGREDIENTS

WATER/EAU BIOSACCHARIDE GUM-1 METHYL GLUCETH-20 GLYCERIN VITIS VINIFERA (GRAPE) SEED OIL DICAPRYLYL CARBONATE METHYLMETHACRYLATE CROSSPOLYMER SACCHARIDE ISOMERATE CETEARYL OLIVATE DIPROPYLENE GLYCOL SORBITAN OLIVATE CANDIDA BOMBICOLA/GLUCOSE/METHYL RAPESEEDATE FERMENT SILICA ALPHA GLUCAN OLIGOSACCHARIDE TALC SODIUM PALMITOYL PROLINE AMMONIUM ACRYLOYL DIMETHYLTAURATE/VP COPOLYMER OLEA EUROPAEA (OLIVE) LEAF EXTRACT NYMPHEA ALBA FLOWER EXTRACT HELIANTHUS ANNUUS (SUNFLOWER) OIL XANTHAN GUM KAEMPFERIA GALANGA (GALANGAL) EXTRACT ROSMARINUS OFFICINALIS (ROSEMARY) OIL SARCOSINE SALVIA SOLAREA (CLARY SAGE) OIL CITRUS AURANTIUM (ORANGE) OIL CITRUS RETICULATA BLANCO (MANDARIN) OIL BUTYLENE GLYCOL GLUCAMINE CHLORPHENESIN CITRUS LIMON (LEMON) OIL CITRUS AURANTIFOLIA (LIME) OIL CYMBOPOGON SCHOENANTHUS (LEMONGRASS) OIL PHENOXYETHANOL ETHYLHEXYLGLYCERIN BHT PVP

In the morning, first cleanse the skin thoroughly. Then apply a thin layer of your specific skin care product. End with the application of the Anti-Shine Moisturizing Lotion SPF 15. Apply prior to sun exposure.

For external use only. Keep out of reach of children. Avoid direct contact with the eyes. If product gets into the eyes, rinse liberally with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor.

PRINCIPAL DISPLAY PANEL

image of tube 50 ml label

image of carton 50ml label

INGREDIENTS AND APPEARANCE

SPF 15 ANTI-SHINE MOISTURIZING 
octinoxate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62499-445
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.77 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
GRAPE SEED OIL (UNII: 930MLC8XGG)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
METHYL METHACRYLATE (UNII: 196OC77688)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
TALC (UNII: 7SEV7J4R1U)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLUCAMINE (UNII: 5QN16UUF80)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POVIDONE K30 (UNII: U725QWY32X)
LESSER GALANGAL ROOT (UNII: 42LD90786Y)
ROSEMARY OIL (UNII: 8LGU7VM393)
SARCOSINE (UNII: Z711V88R5F)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ORANGE OIL (UNII: AKN3KSD11B)
MANDARIN OIL (UNII: NJO720F72R)
CHLORPHENESIN (UNII: I670DAL4SZ)
LEMON OIL (UNII: I9GRO824LL)
LIME OIL (UNII: UZH29XGA8G)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)

Product Characteristics
Color	blue (dark bleu)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62499-445-11	1 in 1 CARTON
1	NDC: 62499-445-04	50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/29/2011

Labeler - Laboratoire Dr Renaud Inc. (202501565)

Registrant - Laboratoire Dr Renaud Inc. (202501565)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoire Dr Renaud Inc.		202501565	manufacture