Label: BABY SUNSCREEN SPF 50- titanium dioxide 3.1% zinc oxide 4.0% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 41250-902-06 - Packager: Meijer
- 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 June 29, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 a doctor if • rash occurs
Keep out of reach of children. If product is swallowed, get medical
help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • Apply liberally 15 minutes before sun exposure
• 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 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-sleeve shirts, pants, hats, and
sunglasses • Children under 6 months: Ask a doctor - OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
Aloe Barbadensis Leaf Extract, Alumina,
Butyloctyl Salicylate, Caprylic/ Capric Triglyceride Caprylyl Glycol Cetyl
PEG/PPG-10/1 Dimethicone, Dimethicone Ethylhexyl Methoxycrylene,
Glycerin, Isohexadecane, Lauryl PEG-8 Dimethicone Octyldodecyl
Citrate Crosspolymer PEG-8, Phenoxyethanol
Sodium Chloride, Sodium Citrate, Tocopheryl
Acetate, Triethoxycaprylylsilane, VP/Eicosene
Copolymer Water. - Questions? 866-483-2846
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BABY SUNSCREEN SPF 50
titanium dioxide 3.1% zinc oxide 4.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-902 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 3.1 g in 100 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Caprylyl Glycol (UNII: 00YIU5438U) Dimethicone (UNII: 92RU3N3Y1O) Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8) Glycerin (UNII: PDC6A3C0OX) Isohexadecane (UNII: 918X1OUF1E) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Phenoxyethanol (UNII: HIE492ZZ3T) Sodium Chloride (UNII: 451W47IQ8X) Sodium Citrate (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-902-06 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/14/2017 Labeler - Meijer (006959555) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(41250-902) , label(41250-902)
