SAFE HARBOR - NATURAL SUNSCREEN FACE AND NECK CREAM BROAD SPECTRUM SPF40 SUNSCREEN- titanium dioxide, zinc oxide cream 
Emilia Personal Care 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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Safe Harbor Natural Suncare

Active ingredient

Titanium Dioxide 12.35%
Zinc Oxide 3.5%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use on

When using this product

Stop use and ask a doctor

Keep Out of Reach of Children

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

Directions

Other information

Inactive ingredients

water, cyclopentasiloxane, caprylic/capric triglyceride, C12-15 alkyl benzoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, trimethoxycaprylylsilane, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), butyrospermum parkii (shea butter), persea gratissima (avocado) oil, cananga odorata (ylang-ylang) flower oil, pelargonium graveolens (geranium) flower oil, citrus aurantium bergamia (bergamot) fruit oil, citrus aurantium dulcis (orange) oil, citrus medica limonum (lemon) peel oil, cymbopogon martini (palmarosa) oil, ellettaria cardamomum (cardamon) seed oil, aloe barbadensis leaf juice, allantoin, panthenol (pro-vitamin B5), lecithin, soy isoflavones, polysorbate 80, astaxanthin, bisabolol, hippophae rhamnoides oil, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis (lemon balm) leaf extract, aspalanthus linearis (rooibos) leaf extract

Package/Label Principal Display Panel

Safe Harbor™ Natural Suncare

Free from chemical UV filters

40 Mineral SPF Broad Spectrum Sunscreen

Face & Neck Cream
With Natural Anti-Aging Complex

Moisturizing sunscreen

Anti-aging treatment
rich in age-defying antioxidants

3 Fl. Oz (88.7 mL)

Distributed by: Emilia Personal Care.
Manufactured in Israel.
For more information visit: www.safeharborsuncare.com

UVA, UVB
With Certified Organic Ingredients
Water Resistant
Allergy Tested

ZX41 2E T1

Label

Label

SAFE HARBOR - NATURAL SUNSCREEN FACE AND NECK CREAM BROAD SPECTRUM SPF40 SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-418
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.35 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TRICAPRYLIN (UNII: 6P92858988)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SHEANUT OIL (UNII: O88E196QRF)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CANANGA OIL (UNII: 8YOY78GNNX)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE OIL (UNII: AKN3KSD11B)  
LEMON OIL (UNII: I9GRO824LL)  
PALMAROSA OIL (UNII: 0J3G3O53ST)  
CARDAMOM (UNII: 8BC4CUT4JL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SOY ISOFLAVONES (UNII: 71B37NR06D)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ASTAXANTHIN (UNII: 8XPW32PR7I)  
LEVOMENOL (UNII: 24WE03BX2T)  
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
CHAMOMILE (UNII: FGL3685T2X)  
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42421-418-1188.7 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/05/2014
Labeler - Emilia Personal Care Inc. (965445112)

Revised: 11/2013
Document Id: 9e2fb9bb-8a79-4675-84df-fd5990f7db1d
Set id: 9e2fb9bb-8a79-4675-84df-fd5990f7db1d
Version: 1
Effective Time: 20131119
 
Emilia Personal Care Inc.