BABYS FIRST KISS SPF 50 BROAD SPECTRUM- sunscreen lotion

Babys First Kiss by

Drug Labeling and Warnings

Babys First Kiss by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient......................Purpose

Titanium Dioxide 6%.................................Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases your risk of skin cancer and early skin aging caused by the sun

Warnings

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occures
• When using this product keep out of eyes. Rinse with water to remove
• Keep out of reach of children
• If swallowed get medical help or contact a Poison Control Center right away

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
      • Children under 6 months: ask a doctor

Sun Protection Measures: Spending time in the sun increases you risk of cancer/skin aging. To decrease risk, use Broad Spectrum sunscreen SPF 15 or higher and other protection measures including:

• Limit time in sun, especially from 10am-2pm
• Wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Bisabolol, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cocos Nucifera (Coconut) Oil, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Vegetable Oil, Jojoba Esters, Lavandula Angustifolia (Lavender) Flower Extract, Oryzanol, Persea Gratissima (Avocado) Oil, Prunus Armeniaca (Apricot) Kernel Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Vitis Vinifera (Grape) Seed Oil

Other Information

Protect product from excessive heat and direct sun

Package label

INGREDIENTS AND APPEARANCE

BABYS FIRST KISS  SPF 50 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
GAMMA ORYZANOL (UNII: SST9XCL51M)
AVOCADO OIL (UNII: 6VNO72PFC1)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-139-20	118 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/20/2015

Labeler - Bell International Laboratories (967781555)