Premium Natural Sunscreen Lotion Baby Bum SPF 30

Premium Natural Sunscreen Loition by

Drug Labeling and Warnings

Premium Natural Sunscreen Loition by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC, Baxter Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREMIUM NATURAL SUNSCREEN LOITION BABY BUM- zinc oxide cream 
Sun Bum LLC

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.

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Premium Natural Sunscreen Lotion Baby Bum SPF 30

Active Ingredient:                 Purpose

Zinc Oxide 22.00% ..............  Sunscreen

Uses

  • Helps preven sunburn
  • If used as directed with other sun protection measures (see Directions), decreasess the risk of skin cancer and early skin aging caused by the sun

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

Stop use and ask a doctor if rash occurs

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

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. Spenidng 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 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Inactive Ingredients:

Aluminum Startch Octenylsuccinate, Beeswax, Betacarotene, Butyrospermum Parkii (shea) Butter, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cucumi Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Euphorbia Cerifera (Candelilla) Wax, Glyceryl Isostearate, Glycine Soya (Soybean) Oil, Parfum, Persea Gratissima (Avocado Oil), Polyhydroxystearic Acid, Rose Hip Seed Oi, Silica, Simmondsia Chinensis (Jojoba) Oil, Tocopherol, Vitis Vinifera (Grape) Seed Oil

Premium Natural Sunscreen Lotion 

Baby Bum 30

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

 3 FL OZ / 88 mL

Box

Lotion

PREMIUM NATURAL SUNSCREEN LOITION  BABY BUM
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69039-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
SHEANUT OIL (UNII: O88E196QRF)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CUCUMBER (UNII: YY7C30VXJT)  
CARROT (UNII: L56Z1JK48B)  
CANDELILLA WAX (UNII: WL0328HX19)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
SOYBEAN (UNII: L7HT8F1ZOD)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69039-104-021 in 1 PACKAGE04/27/201508/31/2018
1NDC: 69039-104-0188 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/27/201508/31/2018
Labeler - Sun Bum LLC (028642574)
Registrant - Sun Bum LLC (028642574)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Laboratories740537709manufacture(69039-104)

Revised: 2/2020
 

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