Label: SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 42421-575-15 - Packager: Emilia Personal Care Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 20, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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; Children
under 6 months: Ask a doctor. -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 value 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 shirts, pants, hats and sunglasses.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients water, caprylic/capric triglyceride, sesamum
indicum (sesame) seed oil, helianthus annuus
(sunflower) seed oil, glycerin, cetearyl alcohol,
cetearyl glucoside, simmondsia chinensis
(jojaba) seed oil, glyceryl stearate,
butyrosperum parkii (shea) butter, potassium
cetyl phosphate, phenoxyethanol, ethylhexylglycerin,
xanthan gum, PEG-40 stearate, trimethoxycaprylsilane, allantoin,
tocopherol acetate (vitamin E), panthenol (pro-vitamin B5),
bisabolol, hippophae rhamnoides oil, avena sativa (oat) kernel extract,
echinacea purpurea root extract, chamomilla recutita (matricaria) flower extract,
tilia vulgaris flower extract, melissa officinalis leaf extract,
aspalathus linearis leaf extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42421-575 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.4 g in 124 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.96 g in 124 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SESAME OIL (UNII: QX10HYY4QV) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) JOJOBA OIL (UNII: 724GKU717M) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) SHEA BUTTER (UNII: K49155WL9Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) PEG-40 STEARATE (UNII: ECU18C66Q7) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) LEVOMENOL (UNII: 24WE03BX2T) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) OAT (UNII: Z6J799EAJK) ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU) MATRICARIA RECUTITA ROOT (UNII: BTG5H50X7F) TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42421-575-15 124 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/15/2015 Labeler - Emilia Personal Care Inc (965445112)