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

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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baby Blanket Broad Spectrum SPF 50

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 to 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 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 - 177 mL Bottle Label

KiDS

by BABY

blanket

Sunscreen Lotion

Titanium Dioxide Formula

BROAD

SPECTRUM

SPF 50+

UVA/UVB Protection

WATER RESISTANT

(80 MINUTES)

Paba-free

Hypoallergenic

Pediatrician &

Dermatologist Tested

NET WT 6 FL OZ (177 mL)

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:58443-0094
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	77.25 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

Ingredient Name	Strength
Inactive Ingredients
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)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0094-4	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/07/2013	12/31/2018

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0094) , pack(58443-0094) , manufacture(58443-0094) , analysis(58443-0094)

Revised: 4/2022

Document Id: dbd94c0a-c70c-442b-e053-2a95a90afa1d

Set id: be3661e1-d596-4580-ad03-f13a53061343

Version: 4

Effective Time: 20220404

Prime Enterprises, Inc.