LBEL DIVINE LIP GLOSS SPF 15- octinoxate and oxybenzone lotion
Ventura Corporation Ltd. (San Juan, P.R)

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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DIVINE LIP GLOSS

Active Ingredients

Octinoxate 7.5%, Oxybenzone 3.0%.

Purpose

Sunscreen.

Uses

Helps prevent sunburn.

Warnings

Stop use if skin rash occurs.

Inactive Ingredients

Hydrogenated polyisobutene, diisopropyl dimer dilinoleate, isostearyl neopentanoate, cera alba (beeswax), silica dimethyl silylate, parfum (fragrance), parfum (fragrance), glycerin, prunus amygdalus dulcis oil (prunus amygdalus dulcis (sweet almond) oil), tocopheryl acetate, cocos nucifera oil (cocos nucifera (coconut) oil), aloe barbadensis leaf extract, hydrogenated vegetable oil, propylparaben, methylparaben, sodium saccharin, bht, citrus limon peel cera (citrus limon (lemon) peel wax), citrus limon peel oil (citrus limon (lemon) peel oil), citrus aurantium dulcis peel oil (citrus aurantium dulcis (orange) peel oil), citrus aurantium dulcis peel cera (citrus aurantium dulcis (orange) peel wax). May Contain: CI 77019 (mica), CI 15850 (red 7 lake), CI 77891 (titanium dioxide ), CI 77491, CI 77492, CI 77499 (iron oxides), CI 19140 (yellow 5 lake), CI 16035 (red 40 lake), CI 42090 (blue 1 lake), CI 75470 (carmine), talc, palmitic acid.

Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 12 ml Bottle Carton

DIVINE LIP GLOSS

Lip gloss SPF 15

12 ml e (.40 fl.oz.)

L'BEL

Principal Display Panel - 12 ml Bottle Carton

LBEL DIVINE LIP GLOSS SPF 15
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 mL in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.03 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
diisopropyl dilinoleate (UNII: 5323S7S2LR)
isostearyl neopentanoate (UNII: 411THY156Q)
yellow wax (UNII: 2ZA36H0S2V)
silica dimethyl silylate (UNII: EU2PSP0G0W)
glycerin (UNII: PDC6A3C0OX)
almond oil (UNII: 66YXD4DKO9)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
coconut oil (UNII: Q9L0O73W7L)
aloe vera leaf (UNII: ZY81Z83H0X)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
saccharin sodium (UNII: SB8ZUX40TY)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
lemon peel wax (UNII: 20G0UPO0TI)
lemon oil (UNII: I9GRO824LL)
orange oil (UNII: AKN3KSD11B)
orange peel wax (UNII: 0U715N387C)
mica (UNII: V8A1AW0880)
D&C red no. 7 (UNII: ECW0LZ41X8)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C red no. 40 (UNII: WZB9127XOA)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
cochineal (UNII: TZ8Z31B35M)
talc (UNII: 7SEV7J4R1U)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-121-01	12 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	11/14/2011

Labeler - Ventura Corporation Ltd. (San Juan, P.R) (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star, S. A.(Colombia)		880160197	MANUFACTURE(13537-121)

Name	Address	ID/FEI	Business Operations
Establishment
Yobel Supply Chain Management (Peru)		934116930	MANUFACTURE(13537-121)