INVINCIBLE SETTING POWDER SPF 45- titanium dioxide, zinc oxide powder

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 CATION - UNII:13S1S8SF37)

Available from:

TAYLOR JAMES, LTD.

INN (International Name):

TITANIUM DIOXIDE

Composition:

TITANIUM DIOXIDE 15.7 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 Stop use and ask a doctor if rash occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

INVINCIBLE SETTING POWDER SPF 45- TITANIUM DIOXIDE, ZINC OXIDE POWDER
TAYLOR JAMES, LTD.
_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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INVINCIBLE SETTING POWDER SPF 45
Active ingredients Purpose
Titanium Dioxide 15.7% Sunscreen
Zinc Oxide 20% Sunscreen
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
Keep out of reach of children
Stop use and ask a doctor if rash occurs
WARNINGS For external use only
Do not on damaged or broken skin
When using this product keep out of eyes
Rinse with water to remove
If swallowed, get medical help or contact a Poison Center right away
DIRECTIONS
Apply liberally and evenly to face before sun exposure
Reapply after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Children under 6 months: Ask a doctor
INACTIVE INGREDIENTS
Silica, Calcium Aluminum Borosilicate, Polymethyl Methacrylate,
Lauroyl
Lysine, Phenoxyethanol, Water (Aqua), Sodium Dehydroacetate, Ascorbyl
palmitate, Ceteareth-25,
Glycerin, Cetyl Alcohol, Cholesterol, Ceramide NP, Behenic Acid,
Ethylhexyglycerin, Ceramide NS,
Ceramide AP, Ceramide EOP, Ceramide EOS, Caprooyl Pytosphingosine,
Caprooyl Sphingosine,
Tocopherol, Titanium Dioxide (CI77891), Iron Oxides (CI 77491)
Invincible Setting Powder
SPF 45
100% mineral. Sweat Resistant
0.09 oz / 2.5 g
INVINCIBLE SETTING POWDER SPF 45
titanium dioxide, zinc oxide powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:759 36 -10 5
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
15.7 g in 10 0 g
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
20