Label: BLUE LIZARD BABY SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion
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NDC Code(s):
0316-2036-10,
0316-2036-30,
0316-2036-40,
0316-2036-45, view more0316-2036-46, 0316-2036-50
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 13, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Drug Facts - Uses
- Helps prevent sunburn and photodamage caused by UVA/UVB exposure
- Higher SPF gives more sunburn protection
- If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
• Shake well prior to use
• Apply liberally to dry skin 15 minutes before sun exposure
• For topical use only
• Keep out of reach of children • Children under 6 months: ask a doctor
• 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.
• Reapply to dry skin: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
- Other Information
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Inactive Ingredients
Alumina, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer
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Blue Lizard Baby 3oz Tube
BLUE LIZARD
AUSTRALIAN SUNSCREEN
50+
UVA/UVB PROTECTION
BROAD SPECTRUM
SPF 50+
PEDIATRICIAN RECOMMENDED
mineral-based
sunscreen brand
BABY
Mineral Sunscreen
Protects your skin by acting like thousands of tiny shields that reflect UV rays.
Smart Cap TECHNOLOGY
CAP CHANGES COLOR IN HARMFUL UV LIGHT
WATER RESISTANT (80 MINUTES)
P11642.01
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INGREDIENTS AND APPEARANCE
BLUE LIZARD BABY SPF 50 SUNSCREEN
titanium dioxide and zinc oxide lotionProduct 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 ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) YELLOW WAX (UNII: 2ZA36H0S2V) 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) 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-2036-30 89 mL in 1 TUBE; Type 0: Not a Combination Product 02/17/2020 2 NDC:0316-2036-40 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/29/2020 3 NDC:0316-2036-50 259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/24/2020 4 NDC:0316-2036-10 5 mL in 1 PACKET; Type 0: Not a Combination Product 03/02/2020 5 NDC:0316-2036-45 148 mL in 1 TUBE; Type 0: Not a Combination Product 02/17/2020 02/17/2020 6 NDC:0316-2036-46 148 mL in 1 TUBE; Type 0: Not a Combination Product 02/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/29/2020 Labeler - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-2036)