Hawaiian Tropic Baby

Dosage form: lotion
Ingredients: OCTOCRYLENE 8mL in 100mL, OXYBENZONE 3.5mL in 100mL
Labeler: Formulated Solutions
NDC Code: 23667-000

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.

Hawaiian Tropic Baby Creme Lotion

Active Ingredients                                                     Purpose
Octocrylene 8 percent , Oxybenzone 3.5 percent        Sunscreen

Uses

helps prevent sunburn

Warnings

For external use only

Do not spray directly into face

When using this product

Avoid spraying in eyes

If contact occurs, rinse thoroughly with water

Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 degrees F



Stop use and ask a doctor if irritation or rash develops.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions  

Apply generously and evenly to all areas 15 minutes before sun exposure

spray on hands to apply to face

use in well-ventilated area

reapply in frequent intervals and after swimming  or towel drying

ask a doctor before use on children under six months of age




Other information

Sun Alert
Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
May stain some fabrics.

inactive Ingredients

Water, Hydrogenated Polysobutene, Lauryl PEG-8, Dimethicone, Butyloxyl Salicylate, Ethylhexyl Palmitate, Hydrated Silica, Cyclopentasiloxane, Cyclohexasiloxane, Retinyl Palmitate (Vitamn A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimithicond, Sodium Propoxyhydroxypropyl Thiosulfate Extract, Octyldodecanol, Silica, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica ( Mango) Fruit Extract, Plumeria Acutifolia (Plumeria) Flower Extact, Colocasla  Antiquorum Root Extract, Psidium Guajava ( Guava) Fruit Extract, Passiflora Incarnata (Passioflower) Fruit Extract,  Aloe Barbadensis Leaf Juice, Beeswax, Disodium EDTA, Microcrystalline Wax, Acrylates C12-22 Alkyl Methacrylate Copolymer, Sodium Chloride, Polyethlene, Stearoxy Dimethicone, Benzyl Alcohol, Methylparaben, Propylparaben, Fragrance

Questions or Comments? call 1-800 NO UV RAY Mon- Fri

New

Hawaiian Tropic

Baby Creme Lotion

pediatrician tested
won't run into eyes
natural island botanicals

50

UVB / SPF

With UVA

Sun Sure

Protection

Protect Pamper Nourish

HAWAIIAN TROPIC BABY 
octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE8 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
ETHYLHEXYL PALMITATE 
HYDRATED SILICA 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
RETINAMIDE 
ASCORBIC ACID 
EDETATE DISODIUM 
SODIUM CHLORIDE 
BENZYL ALCOHOL 
METHYLPARABEN 
ALOE 
Packaging
#Item CodePackage Description
1NDC:23667-000-01177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/26/2010
Labeler - Formulated Solutions (143266687)
Establishment
NameAddressID/FEIOperations
Formulated Solutions143266687manufacture

Revised: 08/2010
 
Formulated Solutions

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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