SAFE HARBOR - NATURAL SUNSCREEN - BABY AND KIDS SPF50 BROAD SPECTRUM SUNSCREEN- titanium dioxide, zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Emilia Personal Care Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen - helps prevent sunburn - If used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. - damaged or broken skin - if rash occurs

Authorization status:

OTC monograph not final

Summary of Product characteristics

SAFE HARBOR - NATURAL SUNSCREEN - BABY AND KIDS SPF50 BROAD SPECTRUM
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._
----------
SAFE HARBOR NATURAL SUNCARE
ACTIVE INGREDIENT
Titanium Dioxide 11.4%
Zinc Oxide 4.0%
PURPOS E
Sunscreen
US ES
helps prevent sunburn
If used as directed with other sun protections 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
STOP USE AND ASK A DOCTOR
if rash occurs
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use water resistant sunscreen if swimming or sweating
Children under 6 months: ask a doctor
SUN PROTECTION MEASURES: Spending time in the sun increases your risk
of sun 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 10a.m. - 2p.m.
limit time in the sun, especially from 10a.m. - 2p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
OTHER INFORMATION
protect the product in this container from excessive heat and direct
sun
INACTIVE INGREDIENTS
water, cyclopentasiloxane, C12-15 alkyl benzoate, caprylic/capric
triglyceride, 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), allantoin,
panthenol (pro-vitamin B5), hippophae
rhamnoides oil, simmondsia chinesis (jojoba) seed