CALIFORNIA NATUREL SPF 30- zinc oxide cream 
Ironwood Clay Company, 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 Active ingredients

Zinc Oxide 20%

Purpose

Sunscreen

Keep out of reach of children.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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 occurs.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply
  • immediately after swimming, sweating or 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, regularity 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-sleeved shirt, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients

Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carrageenan, Carthamus tinctorius (safflower) seed oil, cetearyl alcohol, cetearyl glucoside, cetyl palmitate, coco-caprylate, dimethicone, glucose, glucose oxidase, Helianthus annuus (sunflower) seed oil, isostearic acid, lactoperoxidase, lecithin, lysolecithin, methylcellulose, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, Punica granatum (pomegranate) fruit extract, pullulan, Rosmarinus officinalis (rosemary) leaf extract, sclerotium gum, Sea Silt extract (Glacial Oceanic Mineral Water), sorbitan olivate, sorbitan palmitate, stearyl alcohol, Tagetes erecta flower extract, xanthan gum

Other information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call 415-180-8315 or visit our web site at www.californianaturel.com

california naturel SPF 30 Product Label

california naturel

All Natural Sunscreen

Plant and Mineral-based formula

Broad-spectrum protection

SPF 30

70ml / 2.3 fl. oz.

california naturel  uses only the purest, most luxurious and effective ingredients found in nature.
All california naturel products are naturally scented and free of: parabens, sulfates, and harsh synthetic chemicals.

This box is recyclable and printed with plant-based ink.

All Natural Sunscreen

This soft, luxurious and non-oily all natural sunscreen is formulated with Glacial Oceanic Minerals and Zinc Oxide to protect the skin from both UVA and UVB rays. It is enriched with antioxidants from botanical sources such as Shea Butter, Pomegranate Extract and Marigold Flower Extract to increase skin-hydration, and protect it from enviromental damage.

www californianaturel.com

Dist. by California Naturel, Inc.
San Francisco, CA 94111, USA

01/216


IC CalifNaturel2 Label

IC CalifNaturel3 Label

CALIFORNIA NATUREL  SPF 30
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52311-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE16 g  in 70 mL
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER 
MEDIUM-CHAIN TRIGLYCERIDES 
CARRAGEENAN 
SAFFLOWER SEED 
CETOSTEARYL ALCOHOL 
CETEARYL GLUCOSIDE 
CETYL PALMITATE 
COCO-CAPRYLATE 
DIMETHICONE 
DEXTROSE  
GLUCOSE OXIDASE 
SUNFLOWER OIL 
ISOSTEARIC ACID 
LACTOPEROXIDASE BOVINE 
LECITHIN, SOYBEAN 
METHYLCELLULOSE (100 MPA.S) 
POLYGLYCERYL-3 RICINOLEATE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
POMEGRANATE 
PULLULAN 
ROSEMARY 
BETASIZOFIRAN 
WATER 
SORBITAN OLIVATE 
SORBITAN MONOPALMITATE 
STEARYL ALCOHOL 
TAGETES ERECTA FLOWER 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52311-004-0170 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2014
Labeler - Ironwood Clay Company, Inc. (248997694)
Registrant - Ironwood Clay Company, Inc. (248997694)
Establishment
NameAddressID/FEIBusiness Operations
Ironwood Clay Company, Inc.248997694manufacture(52311-004)

Revised: 2/2014
 
Ironwood Clay Company, Inc.