California Pure Naturals Natural Baby Sunscreen by Dr. J SkinClinic, Inc. / Micro Connection Enterprises, Inc.

California Pure Naturals Natural Baby Sunscreen by

Drug Labeling and Warnings

California Pure Naturals Natural Baby Sunscreen by is a Otc medication manufactured, distributed, or labeled by Dr. J SkinClinic, Inc., Micro Connection Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALIFORNIA PURE NATURALS NATURAL BABY SUNSCREEN SPF 30- zinc oxide lotion 
Dr. J SkinClinic, 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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DRUG FACTS

Zinc Oxide (18%)

Sunscreen

Uses

Helps prevent sunburn

WARNINGS

For External Use Only.

Avoid direct contact with eyes.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

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

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

Directions

Shake well for several seconds, then apply liberally over the face and neck for 15 minutes prior to sun exposure.

*Aloe Barbadensis (Aloe Vera) Leaf Juice, *Rubus Ursinus (California Blackberry) Fruit, *Simmondsia Chinensis (Jojoba) Seed Oil, *Argania Spinosa (Argan) Kernel Oil, *Borago Officinalis (Borage) Seed Oil, *Vaccinium Macrocarpon (Cranberry) Seed Oil, *Rosa Canina (Rosehip) Fruit Oil, Tocopherol, *Rubus Idaeus (Raspberry) Seed Oil, *Carthamus Tinctorius (Safflower) Seed Oil, *Cocos Nucifera (Coconut) Oil, Glycerin, *Tapioca Starch, Silica, Benzyl Alcohol, Glyceryl Caprylate, Glyceryl Undecylenate, Sodium Benzoate, Potassium Sorbate, Lavandula Angustifolia (Lavender) Oil
*Organic

Distributed by

California Pure Naturals

Cerritos, CA

californiapurenaturals.com

PRINCIPAL DISPLAY PANEL

CALIFORNIA

pure

NATURALS

Baby

Natural Baby Sunscreen

SPF30

Broad-spectrum UVA/UVB protection

Cranberry and rosehip botanical oils

120 ml / 4 fl. oz.

CALIFORNIA PURE NATURALS NATURAL BABY SUNSCREEN  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59189-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ROSA MOSCHATA OIL (UNII: J99W255AWF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALIFORNIA BLACKBERRY (UNII: 90G1V0NFRE)
JOJOBA OIL (UNII: 724GKU717M)
RASPBERRY SEED OIL (UNII: 9S8867952A)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGAN OIL (UNII: 4V59G5UW9X)
BORAGE SEED OIL (UNII: F8XAG1755S)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
STARCH, TAPIOCA (UNII: 24SC3U704I)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59189-100-01	120 mL in 1 TUBE; Type 0: Not a Combination Product	11/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/03/2020	01/31/2023

Labeler - Dr. J SkinClinic, Inc. (101497332)

Registrant - Dr. J SkinClinic, Inc. (101497332)

Establishment
Name	Address	ID/FEI	Business Operations
Micro Connection Enterprises, Inc.		144297160	manufacture(59189-100)

Revised: 4/2022

Document Id: dd58616a-7ca7-3c8e-e053-2a95a90aff42

34390-5

Set id: d631f457-6315-54e1-e053-2a95a90a75ab

Version: 2

Effective Time: 20220423