OTC Medication Information: Softlips Pearl Plus Vanilla
SOFTLIPS
PEARL PLUS VANILLA- dimethicone, octinoxate, octisalate, oxybenzone
The Mentholatum Company
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.
Softlips Pearl
Drug Facts
Active ingredient
Octinoxate 7.5%
Octisalate 5%
Purpose
Octinoxate – Sunscreen
Octisalate — Sunscreen
Uses
- helps prevent sunburn
Warnings
Skin Cancer/Skin Agent Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
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
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage and Administration
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: ask a doctor
Other information
- protect this product from excessive heat and direct sun
Inactive ingredients
lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide
Questions or comments?
1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)
Softlips.com
Softlips Vanilla
Drug Facts
Active Ingredient
Dimethicone 2%
Octinoxate 7.5%
Octisalate 3%
Oxybenzone 3%
Purpose
Dimethicone – Skin protectant
Octinoxate – Sunscreen
Octisalate – Sunscreen
Oxybenzone — Sunscreen
Uses
- helps prevent sunburn
- temporarily protects chapped or cracked lips
Warnings
Skin Cancer/Skin Agent Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
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
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage and Administration
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: ask a doctor
Other information
- protect this product from excessive heat and direct sun
Inactive ingredients
ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetate [vitamin E]
Questions or comments?
1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)
Softlips.com
Principal Display Panel
Principal Display Panel
SOFTLIPS
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Labeler — The Mentholatum Company (002105757) |
Registrant — The Mentholatum Company (002105757) |
Establishment | |||
Name | Address | ID/FEI | Operations |
The Mentholatum Company | 002105757 | manufacture (10742-7011) |
Revised: 02/2023 The Mentholatum Company
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/softlips-pearl-plus-vanilla/