BABY BLANKET BROAD SPECTRUM SPF 50- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion

Baby blanket by

Drug Labeling and Warnings

Baby blanket by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5 %, Octisalate 5 %, Oxybenzone 2 %, Titanium Dioxide 2.8 %, and Zinc Oxide  4 %

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the 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.

When using this product keep out of eyes. Rinse with water to remove. Apply a test patch on a small area on the skin before use.

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.

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 of 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

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Disodium EDTA, Glycerin, Isopropyl Palmitate, Methylparaben, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Polyethylene, Polyquaternium-37, PPG-1 Trideceth-6, Propylene Glycol Dicaprylate/Dicaprate, Propylparaben, Tocopheryl Acetate, Water

Other information

• protect this product from excesive heat and direct sun

Questions or Comments?

The Children's Healthcare Research

Group, PO Box 830, Westport, MA 02790

PRINCIPAL DISPLAY PANEL - 180 mL  Bottle Label

Baby

blanket

Sunscreen Lotion

for Babies

Titanium Dioxide Formula

BROAD

SPECTRUM

SPF 50+

WATER RESISTANT

(80 MINUTES)

Paba-free

Hypoallergenic

Pediatrician &

Dermatologist Tested

6.0 FL OZ (180 mL)

INGREDIENTS AND APPEARANCE

BABY BLANKET  BROAD SPECTRUM SPF 50
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	77.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20.6 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30.9 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	41.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0092-4	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/23/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0092) , pack(58443-0092) , manufacture(58443-0092) , analysis(58443-0092)