SUN GOO MINERAL SUN STICK- zinc oxide stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Sun Goo Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SUN GOO MINERAL SUN STICK- ZINC OXIDE STICK
SUN GOO 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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_ACTIVE INGREDIENT (S)_
Zinc Oxide 18%
_PURPOSE_
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.
_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 DOCTOR if rash occurs
KEEP OUT OF REACH OF CHILDREN. If a product is swallowed, get medical
help or contact
a Poison Control Center right away.
_DIRECTIONS_
Apply generously and evenly 15 minutes before sun exposure
Children under 6 months of age ask a doctor
Sun protection measures reapply after 40 minutes of swimming or
sweating,
immediately after towel drying, at least every two hours, spending
time in the sun
increases your risk of skin cancer and early skin aging. To decrease
this risk, regularly
use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun
protection
measures including: limit time in the sun, especially from 10:00 a.m.
– 2:00 p.m. wear
long-sleeved shirts, pants, hats and sunglasses.
_INACTIVE INGREDIENTS_
Olive oil, beeswax, jojoba seed oil, cocoa seed butter, rosemary leaf
extract, shea butter
_OTHER INFORMATION_
Protect the product in this container from excessive heat and direct
sun. Do not use if
the seal is broken
PRODUCT LABEL
SUN GOO MINERAL SUN STICK
zinc oxide stick
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82395-001
ROUTE OF ADMINISTRATION
TOPICAL
Sun Goo Inc
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
18 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
OLIVE OIL (UNII: 6UY