Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Crown Laboratories
079035945
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Blue Lizard Sensitive SPF 50 Sunscreen
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Blue Lizard Sensitive 3 oz Tube
Blue Lizard
Australian Sunscreen
50
SENSITIVE
with soothing organic aloe
MINERAL SUNSCREEN
UVA/UVB PROTECTION
BROAD SPECTRUM SPF 50
WATER RESISTANT
(80 MINUTES)
TRUSTED BY DERMATOLOGISTS
3 fl oz (89 ml)
INDICATIONS & USAGE SECTION
Uses
- helps prevent sunburn
DOSAGE & ADMINISTRATION SECTION
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.
WARNINGS SECTION
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
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 swallowed, get medical help or contact a Poison Control Center right away
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Titanium Dioxide 8%
Zinc Oxide 10%
OTC - PURPOSE SECTION
Purpose
Sunscreen
OTC - QUESTIONS SECTION
Questions?
call800.877.8869or visit www.bluelizardsunscreen.com
OTHER SAFETY INFORMATION
Other information
- protect the product in this container from excessive heat and direct sun
- may stain some fabrics
INACTIVE INGREDIENT SECTION
Inactive ingredients
1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Alumina, Aluminum Stearate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water