BLUE LIZARD BABY SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion

Blue Lizard Baby SPF 50 Sunscreen by

Drug Labeling and Warnings

Blue Lizard Baby SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 8%

Zinc Oxide 10%

Purpose

Sunscreen

Uses

• helps prevent sunburn

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 doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

shake well prior to use

apply liberally 15 minutes before sun exposure

children under 6 months of age: ask a doctor

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 a 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.

Keep out of reach of children

Other information

• protect the product in this container from excessive heat and direct sun
• may stain some fabrics

Inactive ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Alumina, Aluminum Stearate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Tocopherol, (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water

Questions?

call 800.877.8869 or visit www.bluelizardsunscreen.com

Blue Lizard Baby 3 oz Tube

Blue Lizard

AUSTRALIAN SUNSCREEN

50

BABY

with soothing calendula extract & organic aloe

MINERAL SUNSCREEN

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

TRUSTED BY PEDIATRICIANS

3 fl oz (89 ml)

INGREDIENTS AND APPEARANCE

BLUE LIZARD BABY SPF 50 SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	89.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	112 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2036-31	89 mL in 1 TUBE; Type 0: Not a Combination Product	12/02/2024
2	NDC: 0316-2036-47	148 mL in 1 TUBE; Type 0: Not a Combination Product	12/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

Labeler - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-2036)