NDC Code(s) : 0316-2045-10, 0316-2045-30, 0316-2045-40, 0316-2045-50, 0316-2045-60, 0316-2045-45
Packager : Crown Laboratories

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Blue Lizard Sensitive SunscreenTitanium Dioxide and Zinc Oxide LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2045
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE54 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE108 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ETHYLHEXYL STEARATE(UNII: EG3PA2K3K5)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
METHYL GLUCOSE DIOLEATE(UNII: FA9KFJ4Z6P)
CHLORPHENESIN(UNII: I670DAL4SZ)
OCTYLDODECYL NEOPENTANOATE(UNII: X8725R883T)
PEG-7 HYDROGENATED CASTOR OIL(UNII: WE09129TH5)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPANEDIOL(UNII: 5965N8W85T)
WATER(UNII: 059QF0KO0R)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
STEARIC ACID(UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)(UNII: AG75W62QYU)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)(UNII: 25LXE464L2)
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALUMINUM OXIDE(UNII: LMI26O6933)
YELLOW WAX(UNII: 2ZA36H0S2V)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0316-2045-105 mL in 1 PACKET Type 0: Not a Combination Product04/01/2004
2NDC:0316-2045-3089 mL in 1 TUBE Type 0: Not a Combination Product01/03/2006
3NDC:0316-2045-40148 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/08/2003
4NDC:0316-2045-50259 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/03/2005
5NDC:0316-2045-603785 mL in 1 JUG Type 0: Not a Combination Product02/02/2004
6NDC:0316-2045-45148 mL in 1 TUBE Type 0: Not a Combination Product01/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 12/08/2003

LABELER - Crown Laboratories(079035945)

REGISTRANT - Crown Laboratories(079035945)

Establishment
Name Address ID/FEI Business Operations
Crown Laboratories 079035945 manufacture(0316-2045)

PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

SENSITIVE

Mineral Sunscreen

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (40 MINUTES)

Mineral Sunscreen

Protects your skin by acting like thousands of tiny shields that reflect UV rays.

3fl oz (89ml)

P6047.14

BL Sensitive P6047_14